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Clinical Trial Results:
A PHASE 1B/2 OPEN-LABEL STUDY TO EVALUATE SAFETY, CLINICAL ACTIVITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB (MSB0010718C) IN COMBINATION WITH OTHER CANCER IMMUNOTHERAPIES IN PATIENTS WITH ADVANCED MALIGNANCIES

Summary
EudraCT number	2015-002552-27
Trial protocol	NL DE GB FR
Global end of trial date	23 Mar 2023

Results information
Results version number	v2(current)
This version publication date	26 Oct 2024
First version publication date	08 Apr 2024
Other versions	v1
Version creation reason

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

Top of page

Sponsor protocol code

B9991004

ISRCTN number

US NCT number

NCT02554812

WHO universal trial number (UTN)

Other trial identifiers

JAVELIN MEDLEY: Other ID

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, NY 10017

Public contact

Pfizer Inc., Pfizer ClinicalTrials.gov Call Center, 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer Inc., Pfizer ClinicalTrials.gov Call Center, 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

29 Jun 2023

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

23 Mar 2023

Was the trial ended prematurely?

Main objective of the trial

PHASE 1B LEAD-IN: TO ASSESS SAFETY AND TOLERABILITY OF A SINGLE DOSE LEVEL OF AVELUMAB IN COMBINATION WITH INCREASING DOSE LEVELS OF OTHER IMMUNE MODULATORS IN SUBJECTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS IN ORDER TO SELECT THE RP2D(S)/SCHEDULE FOR THE COMBINATION. PHASE 2: TO ASSESS OR OF AVELUMAB IN COMBINATION WITH OTHER IMMUNE MODULATORS IN SUBJECTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

09 Nov 2015

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

7 Years

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 33

Country: Number of subjects enrolled

France: 8

Country: Number of subjects enrolled

Japan: 25

Country: Number of subjects enrolled

Australia: 32

Country: Number of subjects enrolled

Poland: 2

Country: Number of subjects enrolled

Taiwan: 5

Country: Number of subjects enrolled

United Kingdom: 14

Country: Number of subjects enrolled

United States: 290

Worldwide total number of subjects

409

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

220

From 65 to 84 years

184

85 years and over

Subject disposition

Top of page

Recruitment details

Screening details

In this study subjects were evaluated in 5 different combinations with avelumab: Combination (Com) A, B, C, D and F. Each com was planned to be conducted in 2 phases: Phase 1b (lead-in phase) and Phase 2 (expansion phase). Phase 2 was conducted at the selected dose level of avelumab com which was determined safe for subjects in Phase 1b.

Period 1 title

Treatment Phase (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab

Arm description

During phase 1b subjects with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.

Arm type

Experimental

Investigational medicinal product name

Utomilumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

500 mg given mg IV every 4 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab

Arm description

During phase 1b subjects with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Arm type

Experimental

Investigational medicinal product name

Utomilumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

100 mg given mg IV every 4 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab

Arm description

During phase 1b subjects with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Arm type

Experimental

Investigational medicinal product name

Utomilumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

20 mg given IV every 4 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-A Ph-2 Melanoma Utomilumab 100mg+Avelumab

Arm description

During Phase 2 subjects with melanoma received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Arm type

Experimental

Investigational medicinal product name

Utomilumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

100 mg given mg IV every 4 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-A Ph-2 SCCHN Utomilumab 100mg+Avelumab

Arm description

During Phase 2 subjects with Squamous Cell Carcinoma of the Head and Neck (SCCHN) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Arm type

Experimental

Investigational medicinal product name

Utomilumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

100 mg given mg IV every 4 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-A Ph-2 TNBC Utomilumab 100mg+Avelumab

Arm description

During Phase 2 subjects with Triple Negative Breast Cancer (TNBC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Arm type

Experimental

Investigational medicinal product name

Utomilumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

100 mg given mg IV every 4 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-A Ph-2 SCLC Utomilumab 100mg+Avelumab

Arm description

During Phase 2 subjects with Squamous cell lung cancer (SCLC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Arm type

Experimental

Investigational medicinal product name

Utomilumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

100 mg given mg IV every 4 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-A Ph-2 1st line(1L) NSCLC Utomilumab 100mg+Avelumab

Arm description

During Phase 2 subjects with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Arm type

Experimental

Investigational medicinal product name

Utomilumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

100 mg given mg IV every 4 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab

Arm description

During Phase 2 subjects with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.

Arm type

Experimental

Investigational medicinal product name

Utomilumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

100 mg given mg IV every 4 weeks.

Investigational medicinal product name

Avelumab and Utomilumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks and 100 mg given mg IV every 4 weeks.

Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab

Arm description

During Phase 2 subjects with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.

Arm type

Experimental

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Investigational medicinal product name

Avelumab and Utomilumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks and 100 mg given mg IV every 4 weeks.

Com-B Ph-1b PF-04518600 0.3mg/kg +Avelumab

Arm description

During Phase 1b subjects received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.

Arm type

Experimental

Investigational medicinal product name

PF-04518600

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

0.3 mg/kg IV every 2 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-B Ph-1b PF-04518600 1.0 mg/kg +Avelumab

Arm description

During Phase 1b subjects received PF-04518600 1.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.

Arm type

Experimental

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Investigational medicinal product name

PF-04518600

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

1.0 mg/kg IV every 2 weeks.

Com-B Ph-1b PF-04518600 3.0 mg/kg +Avelumab

Arm description

During Phase 1b subjects received PF-04518600 3.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.

Arm type

Experimental

Investigational medicinal product name

PF-04518600

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

3.0 mg/kg IV every 2 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-B Ph-2 NSCLC PF-04518600 0.3 mg/kg +Avelumab

Arm description

During Phase 2 subjects with NSCLC received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.

Arm type

Experimental

Investigational medicinal product name

PF-04518600

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

0.3 mg/kg IV every 2 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-B Ph-2 SCCHN PF-04518600 0.3 mg/kg +Avelumab

Arm description

During Phase 2 subjects with SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.

Arm type

Experimental

Investigational medicinal product name

PF-04518600

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

0.3 mg/kg IV every 2 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-C Ph-1b PD 0360324 50mg +Avelumab

Arm description

During Phase 1b subjects received PD 0360324 50 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.

Arm type

Experimental

Investigational medicinal product name

PD 0360324

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

50 mg IV every 2 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-C Ph-1b PD 0360324 100mg +Avelumab

Arm description

During Phase 1b subjects received PD 0360324 100 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Arm type

Experimental

Investigational medicinal product name

PD 0360324

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

100 mg IV every 2 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-C Ph-1b PD 0360324 150mg +Avelumab

Arm description

During Phase 1b subjects received PD 0360324 150 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Arm type

Experimental

Investigational medicinal product name

PD 0360324

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

150 mg IV every 2 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab

Arm description

During Phase 1b subjects received utomilumab 20 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.

Arm type

Experimental

Investigational medicinal product name

utomilumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

20 mg IV every 4 weeks.

Investigational medicinal product name

PF-04518600

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

0.1 mg/kg IV every 2 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab

Arm description

During Phase 1b subjects received utomilumab 50 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.

Arm type

Experimental

Investigational medicinal product name

utomilumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

50 mg IV every 4 weeks.

Investigational medicinal product name

PF-04518600

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

0.1 mg/kg IV every 2 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab

Arm description

During Phase 1b subjects received utomilumab 20 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.

Arm type

Experimental

Investigational medicinal product name

utomilumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

20 mg IV every 4 weeks.

Investigational medicinal product name

PF-04518600

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

0.3 mg/kg IV every 2 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab

Arm description

During Phase 1b subjects received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.

Arm type

Experimental

Investigational medicinal product name

utomilumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

50 mg IV every 4 weeks.

Investigational medicinal product name

PF-04518600

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

0.3 mg/kg IV every 2 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab

Arm description

During Phase 1b subjects received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.

Arm type

Experimental

Investigational medicinal product name

utomilumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

20 mg IV every 4 weeks.

Investigational medicinal product name

PF-04518600

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

1.0 mg/kg IV every 2 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab

Arm description

During Phase 1b subjects received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.

Arm type

Experimental

Investigational medicinal product name

utomilumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

50 mg IV every 4 weeks.

Investigational medicinal product name

PF-04518600

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

1.0 mg/kg IV every 2 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-F Ph-1b SCCHN CMP-001 10mg +Avelumab

Arm description

During Phase 1b subjects with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 sub-cutaneous [SC] administered at weekly intervals, followed by 5 intra tumoral [IT] administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W. Phase 2 was not planned.

Arm type

Experimental

Investigational medicinal product name

CMP-001

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

10 mg initial 7 doses SC at weekly intervals

Investigational medicinal product name

CMP-001

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intratumoral use

Dosage and administration details

10 mg next 5 doses IT at weekly intervals

Investigational medicinal product name

CMP-001

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intratumoral use

Dosage and administration details

10 mg IT every 2 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg

Arm description

During Phase 1b subjects with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus utomilumab 100 mg administered IV Q4W. Phase 2 was not planned.

Arm type

Experimental

Investigational medicinal product name

CMP-001

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

10 mg initial 7 doses SC at weekly intervals

Investigational medicinal product name

CMP-001

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intratumoral use

Dosage and administration details

10 mg next 5 doses IT at weekly intervals

Investigational medicinal product name

CMP-001

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intratumoral use

Dosage and administration details

10 mg IT every 2 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg

Arm description

During Phase 1b subjects with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus PF-04518600 at 0.3 mg/kg administered IV Q2W. Phase 2 was not planned.

Arm type

Experimental

Investigational medicinal product name

CMP-001

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

10 mg initial 7 doses SC at weekly intervals

Investigational medicinal product name

CMP-001

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intratumoral use

Dosage and administration details

10 mg next 5 doses IT at weekly intervals

Investigational medicinal product name

CMP-001

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intratumoral use

Dosage and administration details

10 mg IT every 2 weeks.

Investigational medicinal product name

Avelumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg given IV every 2 weeks.

Investigational medicinal product name

PF-04518600

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

0.3 mg/kg IV every 2 weeks.

Number of subjects in period 1	Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab	Com-A Ph-2 Melanoma Utomilumab 100mg+Avelumab	Com-A Ph-2 SCCHN Utomilumab 100mg+Avelumab	Com-A Ph-2 TNBC Utomilumab 100mg+Avelumab	Com-A Ph-2 SCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1st line(1L) NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab	Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab	Com-B Ph-1b PF-04518600 0.3mg/kg +Avelumab	Com-B Ph-1b PF-04518600 1.0 mg/kg +Avelumab	Com-B Ph-1b PF-04518600 3.0 mg/kg +Avelumab	Com-B Ph-2 NSCLC PF-04518600 0.3 mg/kg +Avelumab	Com-B Ph-2 SCCHN PF-04518600 0.3 mg/kg +Avelumab	Com-C Ph-1b PD 0360324 50mg +Avelumab	Com-C Ph-1b PD 0360324 100mg +Avelumab	Com-C Ph-1b PD 0360324 150mg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab	Com-F Ph-1b SCCHN CMP-001 10mg +Avelumab	Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg	Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg
Started	29	28	29	28	35	21	10	21	11	11	12	12	8	14	25	10	8	6	12	12	12	12	12	11	6	7	7
Completed	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Not completed	29	28	29	28	35	21	10	21	11	11	12	12	8	14	25	10	8	6	12	12	12	12	12	11	6	7	7
Adverse event, serious fatal	1	2	2	2	-	1	1	1	-	-	-	-	-	-	2	1	1	-	1	2	-	1	1	-	-	-	-
Consent withdrawn by subject	1	-	-	2	2	3	-	-	1	1	-	1	1	1	1	1	3	1	-	2	-	1	-	1	-	-	1
Physician decision	1	-	-	1	-	1	-	-	-	-	1	-	-	-	-	-	1	1	-	1	1	-	1	-	-	-	-
Global deterioration of health status	4	3	3	2	5	-	2	1	1	1	2	1	-	-	-	1	-	-	-	-	-	-	-	-	-	-	-
Adverse event, non-fatal	2	5	3	-	5	-	1	6	2	2	1	2	-	3	1	1	-	1	-	-	-	2	1	1	1	2	1
No longer meets eligibility criter	-	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Study terminated by sponsor	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	1	-	-
Unspecified	-	-	2	3	2	1	-	-	1	1	-	-	1	-	1	-	-	-	-	-	-	2	-	-	-	-	-
Progressive disease	20	16	19	18	21	15	6	13	6	6	8	8	6	10	20	6	3	3	11	7	11	6	9	9	4	5	5
Lost to follow-up	-	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-

Baseline characteristics

Top of page

Reporting group title

Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab

Reporting group description

Reporting group title

Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab

Reporting group description

During phase 1b subjects with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab

Reporting group description

During phase 1b subjects with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-A Ph-2 Melanoma Utomilumab 100mg+Avelumab

Reporting group description

During Phase 2 subjects with melanoma received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-A Ph-2 SCCHN Utomilumab 100mg+Avelumab

Reporting group description

Reporting group title

Com-A Ph-2 TNBC Utomilumab 100mg+Avelumab

Reporting group description

During Phase 2 subjects with Triple Negative Breast Cancer (TNBC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-A Ph-2 SCLC Utomilumab 100mg+Avelumab

Reporting group description

During Phase 2 subjects with Squamous cell lung cancer (SCLC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-A Ph-2 1st line(1L) NSCLC Utomilumab 100mg+Avelumab

Reporting group description

During Phase 2 subjects with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab

Reporting group description

During Phase 2 subjects with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.

Reporting group title

Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab

Reporting group description

During Phase 2 subjects with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.

Reporting group title

Com-B Ph-1b PF-04518600 0.3mg/kg +Avelumab

Reporting group description

During Phase 1b subjects received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.

Reporting group title

Com-B Ph-1b PF-04518600 1.0 mg/kg +Avelumab

Reporting group description

During Phase 1b subjects received PF-04518600 1.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.

Reporting group title

Com-B Ph-1b PF-04518600 3.0 mg/kg +Avelumab

Reporting group description

During Phase 1b subjects received PF-04518600 3.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.

Reporting group title

Com-B Ph-2 NSCLC PF-04518600 0.3 mg/kg +Avelumab

Reporting group description

During Phase 2 subjects with NSCLC received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.

Reporting group title

Com-B Ph-2 SCCHN PF-04518600 0.3 mg/kg +Avelumab

Reporting group description

During Phase 2 subjects with SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.

Reporting group title

Com-C Ph-1b PD 0360324 50mg +Avelumab

Reporting group description

During Phase 1b subjects received PD 0360324 50 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.

Reporting group title

Com-C Ph-1b PD 0360324 100mg +Avelumab

Reporting group description

During Phase 1b subjects received PD 0360324 100 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-C Ph-1b PD 0360324 150mg +Avelumab

Reporting group description

During Phase 1b subjects received PD 0360324 150 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab

Reporting group description

Reporting group title

Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab

Reporting group description

Reporting group title

Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab

Reporting group description

Reporting group title

Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab

Reporting group description

Reporting group title

Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab

Reporting group description

Reporting group title

Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab

Reporting group description

Reporting group title

Com-F Ph-1b SCCHN CMP-001 10mg +Avelumab

Reporting group description

Reporting group title

Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg

Reporting group description

Reporting group title

Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg

Reporting group description

During Phase 1b subjects with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus PF-04518600 at 0.3 mg/kg administered IV Q2W. Phase 2 was not planned.

Reporting group values	Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab	Com-A Ph-2 Melanoma Utomilumab 100mg+Avelumab	Com-A Ph-2 SCCHN Utomilumab 100mg+Avelumab	Com-A Ph-2 TNBC Utomilumab 100mg+Avelumab	Com-A Ph-2 SCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1st line(1L) NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab	Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab	Com-B Ph-1b PF-04518600 0.3mg/kg +Avelumab	Com-B Ph-1b PF-04518600 1.0 mg/kg +Avelumab	Com-B Ph-1b PF-04518600 3.0 mg/kg +Avelumab	Com-B Ph-2 NSCLC PF-04518600 0.3 mg/kg +Avelumab	Com-B Ph-2 SCCHN PF-04518600 0.3 mg/kg +Avelumab	Com-C Ph-1b PD 0360324 50mg +Avelumab	Com-C Ph-1b PD 0360324 100mg +Avelumab	Com-C Ph-1b PD 0360324 150mg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab	Com-F Ph-1b SCCHN CMP-001 10mg +Avelumab	Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg	Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg	Total
Number of subjects	29	28	29	28	35	21	10	21	11	11	12	12	8	14	25	10	8	6	12	12	12	12	12	11	6	7	7	409
Age categorical
Units: Subjects
In utero	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Children (2-11 years)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Adults (18-64 years)	13	14	15	15	21	16	6	8	5	1	8	6	5	6	15	6	6	4	6	6	4	8	7	8	4	3	4	220
From 65-84 years	15	13	13	13	13	5	4	13	6	10	4	6	3	8	10	4	2	2	6	6	7	4	5	3	2	4	2	183
85 years and over	1	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	5
Unknown	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Age Continuous
Units: Years
arithmetic mean (standard deviation)	64.14 ( 11.22 )	60.74 ( 10.85 )	61.52 ( 11.81 )	63.71 ( 10.82 )	61.09 ( 11.80 )	53.33 ( 14.59 )	59.40 ( 12.74 )	65.24 ( 11.05 )	65.27 ( 10.05 )	69.55 ( 4.06 )	54.17 ( 12.55 )	64.75 ( 10.68 )	65.25 ( 10.39 )	66.64 ( 7.15 )	63.04 ( 8.12 )	62.50 ( 12.57 )	56.63 ( 9.32 )	54.33 ( 14.60 )	65.67 ( 10.65 )	63.50 ( 10.89 )	66.67 ( 10.29 )	61.58 ( 6.56 )	59.08 ( 11.29 )	61.36 ( 10.54 )	58.50 ( 16.29 )	66.14 ( 5.27 )	60.00 ( 21.63 )	-
Sex: Female, Male
Units: Subjects
Female	8	10	15	8	4	21	4	9	5	7	5	7	3	9	3	7	3	1	3	3	6	3	3	1	1	0	0	149
Male	21	17	14	20	31	0	6	12	6	4	7	5	5	5	22	3	5	5	9	9	6	9	9	10	5	7	7	259
Unknown	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	1	1	1	2	1	0	2	2	0	0	1	1	0	0	0	1	1	0	2	1	1	0	0	0	0	0	0	18
Not Hispanic or Latino	26	26	27	26	32	19	8	19	11	11	11	11	7	13	25	9	6	6	9	10	11	12	12	11	5	6	7	376
Unknown or Not Reported	2	1	1	0	2	2	0	0	0	0	0	0	1	1	0	0	1	0	1	1	0	0	0	0	1	1	0	15
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Asian	5	5	7	1	4	3	0	1	3	2	0	0	0	2	1	0	0	1	1	3	2	4	1	0	0	0	0	46
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Black or African American	0	3	1	0	2	6	0	2	1	1	2	2	1	1	0	0	0	1	2	0	0	1	0	0	0	1	3	30
White	22	19	21	26	25	10	8	16	6	8	9	8	6	10	23	9	7	4	7	8	10	7	11	11	5	5	4	305
More than one race	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	2	1	0	1	3	2	1	2	1	0	1	2	1	1	1	1	1	0	2	1	0	0	0	0	1	1	0	26

End points

Top of page

Reporting group title

Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab

Reporting group description

Reporting group title

Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab

Reporting group description

During phase 1b subjects with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab

Reporting group description

During phase 1b subjects with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-A Ph-2 Melanoma Utomilumab 100mg+Avelumab

Reporting group description

During Phase 2 subjects with melanoma received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-A Ph-2 SCCHN Utomilumab 100mg+Avelumab

Reporting group description

Reporting group title

Com-A Ph-2 TNBC Utomilumab 100mg+Avelumab

Reporting group description

During Phase 2 subjects with Triple Negative Breast Cancer (TNBC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-A Ph-2 SCLC Utomilumab 100mg+Avelumab

Reporting group description

During Phase 2 subjects with Squamous cell lung cancer (SCLC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-A Ph-2 1st line(1L) NSCLC Utomilumab 100mg+Avelumab

Reporting group description

During Phase 2 subjects with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab

Reporting group description

During Phase 2 subjects with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.

Reporting group title

Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab

Reporting group description

During Phase 2 subjects with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.

Reporting group title

Com-B Ph-1b PF-04518600 0.3mg/kg +Avelumab

Reporting group description

During Phase 1b subjects received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.

Reporting group title

Com-B Ph-1b PF-04518600 1.0 mg/kg +Avelumab

Reporting group description

During Phase 1b subjects received PF-04518600 1.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.

Reporting group title

Com-B Ph-1b PF-04518600 3.0 mg/kg +Avelumab

Reporting group description

During Phase 1b subjects received PF-04518600 3.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.

Reporting group title

Com-B Ph-2 NSCLC PF-04518600 0.3 mg/kg +Avelumab

Reporting group description

During Phase 2 subjects with NSCLC received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.

Reporting group title

Com-B Ph-2 SCCHN PF-04518600 0.3 mg/kg +Avelumab

Reporting group description

During Phase 2 subjects with SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.

Reporting group title

Com-C Ph-1b PD 0360324 50mg +Avelumab

Reporting group description

During Phase 1b subjects received PD 0360324 50 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.

Reporting group title

Com-C Ph-1b PD 0360324 100mg +Avelumab

Reporting group description

During Phase 1b subjects received PD 0360324 100 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-C Ph-1b PD 0360324 150mg +Avelumab

Reporting group description

During Phase 1b subjects received PD 0360324 150 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab

Reporting group description

Reporting group title

Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab

Reporting group description

Reporting group title

Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab

Reporting group description

Reporting group title

Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab

Reporting group description

Reporting group title

Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab

Reporting group description

Reporting group title

Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab

Reporting group description

Reporting group title

Com-F Ph-1b SCCHN CMP-001 10mg +Avelumab

Reporting group description

Reporting group title

Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg

Reporting group description

Reporting group title

Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg

Reporting group description

During Phase 1b subjects with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus PF-04518600 at 0.3 mg/kg administered IV Q2W. Phase 2 was not planned.

Subject analysis set title

Com-A Ph- 1b/2 Utomilumab 100 mg + Avelumab

Subject analysis set type

Full analysis

Subject analysis set description

During Phase 1b/2 subjects with NSCLC, Melanoma, SCCHN, TNBC and SCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. The arms combined based on dose level. This combined arm is applicable to only Anti-Drug Antibody (ADA) outcome measure Combination A.

Subject analysis set title

Com-B Ph-1b/2 PF-04518600 + Avelumab

Subject analysis set type

Full analysis

Subject analysis set description

During Phase 1b subjects received PF- 04518600 0.3 mg/kg and in phase 2 participants with NSCLC and SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. The arms combined based on dose level. This combined arm is applicable to only Anti-Drug Antibody (ADA) outcome measure Combination B.

Primary: Phase 1b Lead-in: Number of Subjects With First 2 Cycles Dose Limiting Toxicity (DLT) for Combination A

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End point title

Phase 1b Lead-in: Number of Subjects With First 2 Cycles Dose Limiting Toxicity (DLT) for Combination A ^[1] ^[2]

End point description

AEs occurred during DLT observation period, attributes to study drug was classified as DLT: Hematologic-Grade (G)4 neutropenia lasting >7 day; Febrile neutropenia; Neutropenic infection; G>=3 thrombocytopenia with bleeding; G4 thrombocytopenia; G4 anemia. Non-Hematologic-Any G3 toxicity, except:Transient (24H)G3 fatigue, local reaction, headache resolved to G1; G3-4 nausea/vomiting controlled by medical therapy within 72H; G3 hypertension controlled by medical therapy; G3 diarrhea improved to G<=2 within 72H after medical therapy; G3 skin toxicity resolved to G<=1 in <7 day after medical therapy; G>=3 amylase/lipase abnormality not associated with pancreatitis;G3 endocrinopathies controlled with medical therapy; Tumor flare phenomenon.G4/G3 CRS lasting >24H despite treatment. Subjects in Ph-1b: safety analysis set, received atleast 75% of dose unless due to treatment-related toxicity/experienced DLT in first 2cycle or completed observation period for first 2 cycle of treatment.

End point type

Primary

End point timeframe

Baseline up to Cycle 2 (up to 8 weeks)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses was planned
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab
Number of subjects analysed	29	28	29
Units: Subjects	0	0	0

No statistical analyses for this end point

Primary: Phase 1b Lead-in: Number of Subjects With First 2 Cycles DLT for Combination D

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End point title

Phase 1b Lead-in: Number of Subjects With First 2 Cycles DLT for Combination D ^[3] ^[4]

End point description

End point type

Primary

End point timeframe

Baseline up to Cycle 2 (up to 8 weeks)

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses was planned
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab
Number of subjects analysed	11	10	11	9	11	8
Units: Subjects	1	0	0	2	1	0

No statistical analyses for this end point

Primary: Phase 1b Lead-in: Number of Subjects With First 2 Cycles DLT for Combination C

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End point title

Phase 1b Lead-in: Number of Subjects With First 2 Cycles DLT for Combination C ^[5] ^[6]

End point description

End point type

Primary

End point timeframe

Baseline up to Cycle 2 (up to 8 weeks)

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses was planned
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-C Ph-1b PD 0360324 50mg +Avelumab	Com-C Ph-1b PD 0360324 100mg +Avelumab	Com-C Ph-1b PD 0360324 150mg +Avelumab
Number of subjects analysed	10	8	6
Units: Subjects	0	0	0

No statistical analyses for this end point

Primary: Phase 1b Lead-in: Number of Subjects With First 2 Cycles DLT for Combination B

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End point title

Phase 1b Lead-in: Number of Subjects With First 2 Cycles DLT for Combination B ^[7] ^[8]

End point description

End point type

Primary

End point timeframe

Baseline up to Cycle 2 (up to 8 weeks)

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses was planned
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-B Ph-1b PF-04518600 0.3mg/kg +Avelumab	Com-B Ph-1b PF-04518600 1.0 mg/kg +Avelumab	Com-B Ph-1b PF-04518600 3.0 mg/kg +Avelumab
Number of subjects analysed	12	12	8
Units: Subjects	0	0	0

No statistical analyses for this end point

Primary: Phase 2: Percentage of Subjects With Confirmed OR as per RECIST v 1.1 by Investigator Assessment for Combination B

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End point title

Phase 2: Percentage of Subjects With Confirmed OR as per RECIST v 1.1 by Investigator Assessment for Combination B ^[9] ^[10]

End point description

OR: CR or PR determined as per to RECIST v1.1 from date of first dose of treatment until date of first documentation of PD, confirmed by repeat assessments performed no less than 4 weeks after first response. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures <10mm. PR: >=30% decrease in sum of measures of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD: >=20% increase in sum of diameters of target lesions, taking as reference of smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm, appearance of one or more new lesions was considered PD. Subjects who received at least one dose of study drug were classified according to the study treatment. If received more than one treatment, then was classified according to first treatment.

End point type

Primary

End point timeframe

From start of the treatment until disease progression or death due to any cause, whichever occurred first (approximately 26 months)

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses was planned
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-B Ph-2 NSCLC PF-04518600 0.3 mg/kg +Avelumab	Com-B Ph-2 SCCHN PF-04518600 0.3 mg/kg +Avelumab
Number of subjects analysed	14	25
Units: Percentage of subjects
number (confidence interval 95%)	14.3 (1.8 to 42.8)	8.0 (1.0 to 26.0)

No statistical analyses for this end point

Primary: Phase 2: Percentage of Subjects With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment for Combination A

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End point title

Phase 2: Percentage of Subjects With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment for Combination A ^[11] ^[12]

End point description

End point type

Primary

End point timeframe

From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 53 months approximately)

Notes
[11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses was planned
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-A Ph-2 Melanoma Utomilumab 100mg+Avelumab	Com-A Ph-2 SCCHN Utomilumab 100mg+Avelumab	Com-A Ph-2 TNBC Utomilumab 100mg+Avelumab	Com-A Ph-2 SCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1st line(1L) NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab	Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab
Number of subjects analysed	28	35	21	10	21	11	11
Units: Percentage of subjects
number (confidence interval 95%)	10.7 (2.3 to 28.2)	8.6 (1.8 to 23.1)	14.3 (3.0 to 36.3)	10.0 (0.3 to 44.5)	4.8 (0.1 to 23.8)	54.5 (23.4 to 83.3)	18.2 (2.3 to 51.8)

No statistical analyses for this end point

Primary: Phase 1b Lead-in: Number of Subjects With First Cycle DLT for Combination F

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End point title

Phase 1b Lead-in: Number of Subjects With First Cycle DLT for Combination F ^[13] ^[14]

End point description

End point type

Primary

End point timeframe

Baseline up to first Cycle (up to 4 weeks)

Notes
[13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses was planned
[14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-F Ph-1b SCCHN CMP-001 10mg +Avelumab	Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg	Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg
Number of subjects analysed	6	6	6
Units: Subjects	1	1	0

No statistical analyses for this end point

Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination A

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End point title

Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination A ^[15]

End point description

TEAEs=events with onset dates occurring during on-treatment period for first time, or if worsening of an event is during on-treatment period. Treatment-related AE: any untoward medical occurrence attributed to study drug in subject who received study drug. Per NCI CTCAE v4.03: Grade 3 (Severe) event=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment; Grade 4 (Life-threatening)=caused subject to be in imminent danger of death; Grade 5 (Death)=death related to an AE. Serious AE (SAE)=AE resulting in any of following outcomes: death; initial or prolonged in subject hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Subjects who received at least one dose of drug were classified according to treatment received. If subject received more than one study treatment, then subject was classified according to first treatment.

End point type

Secondary

End point timeframe

Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 6.5 years)

Notes
[15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab	Com-A Ph-2 Melanoma Utomilumab 100mg+Avelumab	Com-A Ph-2 SCCHN Utomilumab 100mg+Avelumab	Com-A Ph-2 TNBC Utomilumab 100mg+Avelumab	Com-A Ph-2 SCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1st line(1L) NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab	Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab
Number of subjects analysed	29	27	29	28	35	21	10	21	11	11
Units: Subjects
TEAEs	29	27	29	28	35	20	10	21	11	11
Grade >=3 TEAEs	15	13	18	13	19	9	7	12	8	6
Serious TEAEs	11	12	13	9	16	4	4	8	4	1
Treatment related TEAEs	22	22	25	23	26	15	8	19	10	9

No statistical analyses for this end point

Secondary: Number of Subjects With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination B

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End point title

Number of Subjects With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination B ^[16]

End point description

End point type

Secondary

End point timeframe

Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 3.5 years)

Notes
[16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-B Ph-1b PF-04518600 0.3mg/kg +Avelumab	Com-B Ph-1b PF-04518600 1.0 mg/kg +Avelumab	Com-B Ph-1b PF-04518600 3.0 mg/kg +Avelumab	Com-B Ph-2 NSCLC PF-04518600 0.3 mg/kg +Avelumab	Com-B Ph-2 SCCHN PF-04518600 0.3 mg/kg +Avelumab
Number of subjects analysed	12	12	8	14	25
Units: Subjects
TEAEs	12	12	8	14	25
Grade >=3 TEAEs	4	6	4	7	13
Serious TEAEs	3	4	1	3	10
Treatment related TEAEs	7	7	7	12	14

No statistical analyses for this end point

Secondary: Number of Subjects With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination C

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End point title

Number of Subjects With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination C ^[17]

End point description

End point type

Secondary

End point timeframe

Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 1.8 years)

Notes
[17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-C Ph-1b PD 0360324 50mg +Avelumab	Com-C Ph-1b PD 0360324 100mg +Avelumab	Com-C Ph-1b PD 0360324 150mg +Avelumab
Number of subjects analysed	10	8	6
Units: Subjects
TEAEs	9	8	6
Grade >=3 TEAEs	5	4	6
Serious TEAEs	4	3	4
Treatment related TEAEs	7	6	5

No statistical analyses for this end point

Secondary: Number of Subjects With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination D

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End point title

Number of Subjects With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination D ^[18]

End point description

End point type

Secondary

End point timeframe

Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 4.5 years)

Notes
[18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab
Number of subjects analysed	12	12	12	12	12	11
Units: Subjects
TEAEs	12	12	12	12	12	11
Grade >=3 TEAEs	5	8	5	7	6	9
Serious TEAEs	2	3	4	5	4	5
Treatment related TEAEs	7	11	9	10	10	8

No statistical analyses for this end point

Secondary: Number of Subjects With New Abnormal or Worsening Hematology Laboratory Test by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3: Combination A

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End point title

Number of Subjects With New Abnormal or Worsening Hematology Laboratory Test by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3: Combination A ^[19]

End point description

Laboratory results were graded according to the NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Shift tables were provided to examine the distribution of laboratory toxicities. Subjects with any grade >=3 is presented for following parameters: lymphocyte count decreased, Platelet count decreased, neutrophil count decreased, and white blood cell decreased. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment. All subjects who received at least one dose of study drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Subjects were classified as per study treatment received. If subject received more than one treatment, subject was classified as per to first treatment received. "N’’=number of subjects evaluable for this endpoint, n=number of subjects evaluable for specified rows.

End point type

Secondary

End point timeframe

Baseline up to end of treatment/withdrawal (maximum of 6.5 years)

Notes
[19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab	Com-A Ph-2 Melanoma Utomilumab 100mg+Avelumab	Com-A Ph-2 SCCHN Utomilumab 100mg+Avelumab	Com-A Ph-2 TNBC Utomilumab 100mg+Avelumab	Com-A Ph-2 SCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1st line(1L) NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab	Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab
Number of subjects analysed	28	27	29	28	34	21	10	21	11	11
Units: Subjects
Decreased Anemia	1	0	0	1	1	0	1	0	0	0
Decreased Lymphocyte	7	3	6	2	6	2	0	2	0	2
Decreased Neutrophil Count	0	0	0	0	0	0	0	1	0	0
Decreased Platelet Count	0	0	0	1	0	1	0	0	0	0
Decreased White Blood Cell	0	0	0	0	0	0	0	1	0	0

No statistical analyses for this end point

Secondary: Number of Subjects With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination F

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End point title

Number of Subjects With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination F ^[20]

End point description

End point type

Secondary

End point timeframe

Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 3 years)

Notes
[20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-F Ph-1b SCCHN CMP-001 10mg +Avelumab	Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg	Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg
Number of subjects analysed	6	7	7
Units: Subjects
TEAEs	6	7	7
Grade >=3 TEAEs	4	5	6
Serious TEAEs	2	4	4
Treatment related TEAEs	6	6	7

No statistical analyses for this end point

Secondary: Number of Subjects With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination B

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End point title

Number of Subjects With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination B ^[21]

End point description

End point type

Secondary

End point timeframe

Baseline up to end of treatment/withdrawal (maximum of 3.5 years)

Notes
[21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-B Ph-1b PF-04518600 0.3mg/kg +Avelumab	Com-B Ph-1b PF-04518600 1.0 mg/kg +Avelumab	Com-B Ph-1b PF-04518600 3.0 mg/kg +Avelumab	Com-B Ph-2 NSCLC PF-04518600 0.3 mg/kg +Avelumab	Com-B Ph-2 SCCHN PF-04518600 0.3 mg/kg +Avelumab
Number of subjects analysed	12	12	8	14	24
Units: Subjects
Subjects with any grade >= 3 Anemia,	1	2	0	0	0
Lymphocyte Count Decreased	1	3	1	3	8
Neutrophil Count Decreased	0	0	0	0	0
Platelet Count Decreased	0	0	0	1	0
White Blood Cell Decreased	0	0	0	0	0

No statistical analyses for this end point

Secondary: Number of Subjects With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination C

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End point title

Number of Subjects With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination C ^[22]

End point description

End point type

Secondary

End point timeframe

Baseline up to end of treatment/withdrawal (maximum of 1.8 years)

Notes
[22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-C Ph-1b PD 0360324 50mg +Avelumab	Com-C Ph-1b PD 0360324 100mg +Avelumab	Com-C Ph-1b PD 0360324 150mg +Avelumab
Number of subjects analysed	10	8	6
Units: Subjects
Any grade >= 3 Anemia	1	1	0
Any grade >=3 Lymphocyte Count Decreased	1	1	1
Any grade >= 3 Neutrophil Count Decreased	0	1	0
Any grade >= 3 Platelet Count Decreased	0	0	0
Any grade >= 3 White Blood Cell Decreased	0	1	0

No statistical analyses for this end point

Secondary: Number of Subjects With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination D

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End point title

Number of Subjects With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination D ^[23]

End point description

End point type

Secondary

End point timeframe

Baseline up to end of treatment/withdrawal (maximum of 4.5 years)

Notes
[23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab
Number of subjects analysed	11	12	12	11	12	11
Units: Subjects
Any grade >= 3 Anemia	0	1	1	0	0	0
Any grade >=3 Lymphocyte Count Decreased	3	6	6	2	3	1
Any grade >= 3 Neutrophil Count Decreased	0	0	0	0	0	0
Any grade >= 3 Platelet Count Decreased	0	0	1	0	1	0
Any grade >= 3 White Blood Cell Decreased	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Number of Subjects With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination F

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End point title

Number of Subjects With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination F ^[24]

End point description

End point type

Secondary

End point timeframe

Baseline up to end of treatment/withdrawal (maximum of 3 years)

Notes
[24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-F Ph-1b SCCHN CMP-001 10mg +Avelumab	Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg	Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg
Number of subjects analysed	5	7	7
Units: Subjects
Any grade >= 3 Anemia	0	2	2
Any grade >=3 Lymphocyte Count Decreased	1	3	1
Any grade >= 3 Neutrophil Count Decreased	1	0	0
Any grade >= 3 Platelet Count Decreased	0	1	1
Any grade >= 3 White Blood Cell Decreased	0	0	0

No statistical analyses for this end point

Secondary: Number of Subjects With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination A

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End point title

Number of Subjects With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination A ^[25]

End point description

Laboratory results were graded as per NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Number of subjects with new abnormal or worsening chemistry laboratory test is presented.” Subjects with any grade >=3 is presented for parameters: Alanine aminotransferase increased(AA), alkaline phosphatase increased(AP), aspartate aminotransferase increased(AAM), blood bilirubin increased, creatinine increased, hyperglycemia, lipase increased and serum amylase (SA) increased. Subjects who received at least one dose of drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Subjects were classified according to study treatment received. If subject received more than one study treatment, subject was classified according to first treatment. "N’’=number of subjects evaluable for this endpoint, where n=number of subjects evaluable for specified rows.

End point type

Secondary

End point timeframe

Baseline up to end of treatment/withdrawal (maximum of 6.5 years)

Notes
[25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab	Com-A Ph-2 Melanoma Utomilumab 100mg+Avelumab	Com-A Ph-2 SCCHN Utomilumab 100mg+Avelumab	Com-A Ph-2 TNBC Utomilumab 100mg+Avelumab	Com-A Ph-2 SCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1st line(1L) NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab	Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab
Number of subjects analysed	28	27	29	28	34	21	10	21	11	11
Units: Subjects
Any grade(G) >= 3 AA Increased	1	1	0	0	0	1	0	1	0	0
Any G >= 3 AP Increased	0	1	0	1	1	0	0	0	0	0
Any G >= 3 AAM Increased	1	1	0	0	0	2	0	0	0	1
Any G>= 3 Blood Bilirubin Increased	1	0	0	0	0	1	0	0	0	0
Any G >= 3 Creatinine Increased	0	0	1	0	0	0	1	0	0	0
Any G >= 3 Hyperglycemia	2	0	1	1	2	1	1	0	1	3
Any G>=3 Lipase Inc,n=28.27,29,28,34,21,9,20,11,11	3	0	2	4	1	2	0	1	0	2
Any G>= 3 SA Inc,n=28.27,29,28,34,21,9,20,11,11	2	1	1	0	0	2	0	2	0	1

No statistical analyses for this end point

Secondary: Number of Subjects With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination B

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End point title

Number of Subjects With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination B ^[26]

End point description

Laboratory results were graded as per NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Number of subjects with new abnormal or worsening chemistry laboratory test is presented.” Subjects with any grade >=3 is presented for parameters: Alanine aminotransferase increased(AA), alkaline phosphatase increased(AP), aspartate aminotransferase increased(AAM), blood bilirubin increased, creatinine increased, hyperglycemia, lipase increased and serum amylase increased. Subjects who received at least one dose of drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Subjects were classified according to study treatment received. If subject received more than one study treatment, subject was classified according to first treatment. "N’’=number of subjects evaluable for this endpoint, where n=number of subjects evaluable for specified rows.

End point type

Secondary

End point timeframe

Baseline up to end of treatment/withdrawal (maximum of 3.5 years)

Notes
[26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-B Ph-1b PF-04518600 0.3mg/kg +Avelumab	Com-B Ph-1b PF-04518600 1.0 mg/kg +Avelumab	Com-B Ph-1b PF-04518600 3.0 mg/kg +Avelumab	Com-B Ph-2 NSCLC PF-04518600 0.3 mg/kg +Avelumab	Com-B Ph-2 SCCHN PF-04518600 0.3 mg/kg +Avelumab
Number of subjects analysed	12	12	8	14	24
Units: Subjects
Any G >= 3 AA Increased	0	0	0	0	0
Any G >= 3 AP Increased	1	0	0	0	0
Any G >= 3 AAM Increased	1	0	0	0	0
Any G >= 3 Blood Bilirubin Increased	0	0	0	0	0
Any G >= 3 Creatinine Increased	0	0	0	0	1
Any G >= 3 Hyperglycemia	1	0	0	0	2
Any G >= 3 Lipase Increased	1	1	1	4	5
Any G >= 3 Serum Amylase Increased	0	0	0	1	0

No statistical analyses for this end point

Secondary: Number of Subjects With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination C

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End point title

Number of Subjects With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination C ^[27]

End point description

Laboratory results were graded as per NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Number of subjects with new abnormal or worsening chemistry laboratory test is presented.” Subjects with any grade >=3 is presented for parameters: Alanine aminotransferase increased(AA), alkaline phosphatase increased(AP), aspartate aminotransferase increased(AAM), blood bilirubin increased, creatinine increased, hyperglycemia, lipase increased and serum amylase increased. Subjects who received at least one dose of drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Subjects were classified according to study treatment received. If subject received more than one study treatment, subject was classified according to first treatment. "N’’=number of subjects evaluable for this endpoint, where n=number of subjects evaluable for specified rows.

End point type

Secondary

End point timeframe

Baseline up to end of treatment/withdrawal (maximum of 1.8 years)

Notes
[27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-C Ph-1b PD 0360324 50mg +Avelumab	Com-C Ph-1b PD 0360324 100mg +Avelumab	Com-C Ph-1b PD 0360324 150mg +Avelumab
Number of subjects analysed	10	8	6
Units: Subjects
Any G >= 3 AA Increased	0	0	2
Any G >= 3 AP Increased	0	0	0
Any G >= 3 AAM Increased	0	0	1
Any G >= 3 Blood Bilirubin Increased	0	0	0
Any G >= 3 Creatinine Increased	0	0	0
Any G >= 3 Hyperglycemia	2	0	2
Any G >= 3 Lipase Increased	1	3	2
Any G >= 3 Serum Amylase Increased	0	1	0

No statistical analyses for this end point

Secondary: Number of Subjects With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination D

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End point title

Number of Subjects With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination D ^[28]

End point description

Laboratory results were graded as per NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Number of subjects with new abnormal or worsening chemistry laboratory test is presented.” Subjects with any grade >=3 is presented for parameters: Alanine aminotransferase increased(AA), alkaline phosphatase increased(AP), aspartate aminotransferase increased(AAM), blood bilirubin increased, creatinine increased, hyperglycemia, lipase increased and serum amylase increased. Subjects who received at least one dose of drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Subjects were classified according to study treatment received. If subject received more than one study treatment, subject was classified according to first treatment. "N’’=number of subjects evaluable for this endpoint, where n=number of subjects evaluable for specified rows.

End point type

Secondary

End point timeframe

Baseline up to end of treatment/withdrawal (maximum of 4.5 years)

Notes
[28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab
Number of subjects analysed	11	12	12	11	12	11
Units: Subjects
Any G >= 3 AA Increased	0	0	0	1	0	1
Any G >= 3 AP Increased	0	0	0	0	0	1
Any G >= 3 AAM Increased	0	0	0	1	0	1
Any G >= 3 Blood Bilirubin Increased	0	0	0	0	0	1
Any G >= 3 Creatinine Increased	0	0	0	0	0	0
Any G >= 3 Hyperglycemia	1	1	0	1	2	1
Any G >= 3 Lipase Increased	0	3	2	2	2	1
Any G >= 3 Serum Amylase Increased	0	0	0	0	0	1

No statistical analyses for this end point

Secondary: Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination A

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End point title

Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination A ^[29]

End point description

Cmax is maximum plasma concentration. All subjects who received at least one dose of study drug and who had at least one of the PK concentrations for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of subjects analyzed’’ signifies number of subjects evaluable for this endpoint, where “Number Analyzed” signifies number of subjects evaluable for specified time points. For ‘’Phase 2 1L NSCLC: Utomilumab then Utomilumab + Avelumab’’ reporting group PK sampling started from Cycle 2 Day 1. 99999 indicates Geometric Coefficient of Variation was not estimable as there was one subject. 88888 indicates Geometric Mean and Geometric Coefficient of Variation was not estimable as there were less number of subjects.

End point type

Secondary

End point timeframe

1-hour post-dose (at end of infusion) on Day 1,15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Day 1 of Cycle 2, 4, 6, 10. For ‘’Phase 2 1L NSCLC: Utomilumab then Utomilumab + Avelumab’’ reporting group: Day 1 of Cycle 2, 4, 6, 10

Notes
[29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab	Com-A Ph-2 Melanoma Utomilumab 100mg+Avelumab	Com-A Ph-2 SCCHN Utomilumab 100mg+Avelumab	Com-A Ph-2 TNBC Utomilumab 100mg+Avelumab	Com-A Ph-2 SCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1st line(1L) NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab	Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab
Number of subjects analysed	28	27	29	26	29	21	9	20	7	10
Units: Nanogram per milliliter
geometric mean (geometric coefficient of variation)
Cycle1/Day1-1 H/EOI, n=22,27,24,24,2,19,9,16,0,9	232.6 ( 39 )	219.0 ( 26 )	231.2 ( 37 )	262.0 ( 56 )	209.0 ( 31 )	215.5 ( 26 )	284.2 ( 16 )	218.6 ( 29 )	88888 ( 88888 )	194.4 ( 27 )
Cycle1/Day8-168 H, n=28,26,29,26,27,21,8,20,0,10	63.60 ( 52 )	59.86 ( 65 )	61.49 ( 84 )	73.57 ( 78 )	69.14 ( 43 )	60.03 ( 33 )	51.85 ( 36 )	45.69 ( 25 )	88888 ( 88888 )	34.46 ( 45 )
Cycle1/Day15-1 H/EOI, n=18,21,24,24,26,15,5,12,0,9	212.1 ( 84 )	226.1 ( 26 )	253.6 ( 31 )	279.4 ( 33 )	238.9 ( 26 )	241.9 ( 29 )	324.6 ( 27 )	221.2 ( 23 )	88888 ( 88888 )	193.7 ( 24 )
Cycle2/Day1-1 H/EOI, n=16,20,20,22,28,11,4,12,7,6	276.0 ( 33 )	229.0 ( 33 )	267.9 ( 31 )	255.5 ( 72 )	223.4 ( 30 )	292.0 ( 18 )	302.5 ( 23 )	222.0 ( 29 )	200.1 ( 20 )	203.3 ( 16 )
Cycle4/Day1-1 H/EOI, n=8,8,10,10,15,6,1,6,5,6	258.4 ( 18 )	232.8 ( 20 )	285.6 ( 16 )	303.1 ( 79 )	209.5 ( 22 )	283.0 ( 27 )	215.0 ( 99999 )	273.5 ( 18 )	206.9 ( 13 )	97.46 ( 237 )
Cycle6/Day1-1 H/EOI, n=8,6,5,5,13,5,2,4,5,4	248.4 ( 32 )	211.1 ( 20 )	193.2 ( 121 )	512.8 ( 126 )	217.1 ( 28 )	305.9 ( 18 )	332.9 ( 3 )	275.2 ( 42 )	208.3 ( 17 )	218.3 ( 11 )
Cycle10/Day1-1 H/EOI, n=5,4,4,4,5,2,1,1,3,3	230.0 ( 48 )	180.5 ( 39 )	328.1 ( 14 )	248.4 ( 14 )	228.1 ( 20 )	187.2 ( 73 )	335.0 ( 99999 )	102.0 ( 99999 )	251.2 ( 14 )	89.72 ( 374 )

No statistical analyses for this end point

Secondary: Number of Subjects With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination F

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End point title

Number of Subjects With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination F ^[30]

End point description

Laboratory results were graded as per NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Number of subjects with new abnormal or worsening chemistry laboratory test is presented.” Subjects with any grade >=3 is presented for parameters: Alanine aminotransferase increased(AA), alkaline phosphatase increased(AP), aspartate aminotransferase increased(AAM), blood bilirubin increased, creatinine increased, hyperglycemia, lipase increased and serum amylase increased. Subjects who received at least one dose of drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Subjects were classified according to study treatment received. If subject received more than one study treatment, subject was classified according to first treatment. "N’’=number of subjects evaluable for this endpoint, where n=number of subjects evaluable for specified rows.

End point type

Secondary

End point timeframe

Baseline up to end of treatment/withdrawal (maximum of 3 years)

Notes
[30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-F Ph-1b SCCHN CMP-001 10mg +Avelumab	Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg	Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg
Number of subjects analysed	5	7	7
Units: Subjects
Any G >= 3 AA Increased	0	0	0
Any G >= 3 AP Increased	0	0	0
Any G >= 3 AAM Increased	0	1	0
Any G >= 3 Blood Bilirubin Increased	0	0	0
Any G >= 3 Creatinine Increased	0	0	0
Any G >= 3 Hyperglycemia	0	0	1
Any G >= 3 Lipase Increased	1	0	1
Any G >= 3 Serum Amylase Increased	1	0	0

No statistical analyses for this end point

Secondary: Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination A

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End point title

Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination A ^[31]

End point description

End point type

Secondary

End point timeframe

1-hour post-infusion (at end of infusion) on Day 1 of Cycle 1,3,5,8,12; Day 8 of Cycle 1 (non-dosing). For ‘’Phase 2 1L NSCLC: Avelumab then Utomilumab + Avelumab’’ reporting group: Day 1 of Cycle 3,5,8,12

Notes
[31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab	Com-A Ph-2 Melanoma Utomilumab 100mg+Avelumab	Com-A Ph-2 SCCHN Utomilumab 100mg+Avelumab	Com-A Ph-2 TNBC Utomilumab 100mg+Avelumab	Com-A Ph-2 SCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1st line(1L) NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab	Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab
Number of subjects analysed	28	27	29	28	32	21	10	20	10	7
Units: Nanogram per milliliter
geometric mean (geometric coefficient of variation)
Cycle1/Day1-1 H/EOI, n=27,27,28,28,32,21,10,19,9,0	106500 ( 31 )	27250 ( 30 )	4673 ( 45 )	23520 ( 34 )	26960 ( 24 )	23780 ( 39 )	20790 ( 39 )	20570 ( 28 )	26020 ( 35 )	88888 ( 88888 )
Cycle1/Day8-168 H, n=28,26,29,26,27,21,8,20,10,0	15940 ( 126 )	4584 ( 93 )	1070 ( 38 )	5740 ( 73 )	7344 ( 60 )	8692 ( 56 )	5036 ( 35 )	6671 ( 41 )	7185 ( 135 )	88888 ( 88888 )
Cycle3/Day1-1 H/EOI, n=16,12,21,14,16,8,3,9,8,7	132000 ( 19 )	26250 ( 19 )	6446 ( 58 )	26210 ( 26 )	28880 ( 31 )	35950 ( 21 )	15170 ( 26 )	20190 ( 66 )	27710 ( 35 )	26710 ( 21 )
Cycle5/Day1-1 H/EOI, n=10,6,7,8,14,7,3,5,6,7	134800 ( 29 )	26470 ( 70 )	5800 ( 48 )	32630 ( 51 )	28370 ( 25 )	28000 ( 36 )	11270 ( 98 )	19440 ( 48 )	25650 ( 30 )	15410 ( 141 )
Cycle8/Day1-1 H/EOI, n=7,4,4,6,5,4,2,2,6,5	121800 ( 28 )	13340 ( 951 )	6067 ( 20 )	38930 ( 85 )	19870 ( 92 )	20710 ( 38 )	20710 ( 22 )	16750 ( 34 )	21680 ( 22 )	18080 ( 89 )
Cycle12/Day1-1 H/EOI, n=6,3,4,5,2,3,0,1,3,3	124800 ( 30 )	19800 ( 62 )	6892 ( 26 )	44690 ( 225 )	20460 ( 8 )	27030 ( 28 )	88888 ( 88888 )	12900 ( 99999 )	20730 ( 33 )	24060 ( 1 )

No statistical analyses for this end point

Secondary: Maximum Observed Plasma Concentration (Cmax) of Avelumab and PF-04518600 in Combination B

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End point title

Maximum Observed Plasma Concentration (Cmax) of Avelumab and PF-04518600 in Combination B ^[32]

End point description

Cmax is maximum plasma concentration. PK analysis set included all subjects who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of subjects analyzed’’ signifies number of subjects evaluable for this endpoint, where “Number Analyzed” signifies number of subjects evaluable for specified time points. 99999 indicates Geometric Coefficient of Variation was not estimable as there was one subject. 88888 indicates Geometric Mean and Geometric Coefficient of Variation was not estimable as there were less number of subjects.

End point type

Secondary

End point timeframe

1-hour post-dose on Day 1,15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Day 1 of Cycle 2, 4, 6 and Cycle 10

Notes
[32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-B Ph-1b PF-04518600 0.3mg/kg +Avelumab	Com-B Ph-1b PF-04518600 1.0 mg/kg +Avelumab	Com-B Ph-1b PF-04518600 3.0 mg/kg +Avelumab	Com-B Ph-2 NSCLC PF-04518600 0.3 mg/kg +Avelumab	Com-B Ph-2 SCCHN PF-04518600 0.3 mg/kg +Avelumab
Number of subjects analysed	12	12	8	13	23
Units: Nanogram per milliliter
geometric mean (geometric coefficient of variation)
Avelumab Cycle1/Day1-1 H/EOI, n=9,12,7,11,22	220.6 ( 26 )	257.6 ( 65 )	213.7 ( 30 )	219.8 ( 22 )	178.4 ( 31 )
Avelumab Cycle1/Day8-168 H, n=11,11,8,13,23	54.00 ( 51 )	42.66 ( 50 )	49.85 ( 45 )	50.86 ( 35 )	47.68 ( 33 )
Avelumab Cycle1/Day15-1 H/EOI, n=7,10,6,9,20	241.9 ( 23 )	240.3 ( 17 )	228.7 ( 33 )	235.5 ( 29 )	180.3 ( 68 )
Avelumab Cycle2/Day1-1 H/EOI, n=8,8,6,10,20	242.8 ( 22 )	256.2 ( 18 )	277.1 ( 27 )	249.1 ( 22 )	188.4 ( 22 )
Avelumab Cycle4/Day1-1 H/EOI, n=3,2,2,6,11	223.9 ( 19 )	204.1 ( 44 )	254.4 ( 10 )	184.9 ( 31 )	205.6 ( 21 )
Avelumab Cycle6/Day1-1 H/EOI, n=0,1,0,3,5	88888 ( 88888 )	143.0 ( 99999 )	88888 ( 88888 )	280.6 ( 18 )	137.0 ( 110 )
Avelumab Cycle10/Day1-1 H/EOI, n=0,0,0,1,4	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	231.0 ( 99999 )	197.2 ( 13 )
PF- 04518600 Cycle1/Day1-1 H/EOI, n=12,12,7,12,23	6413 ( 21 )	21560 ( 25 )	74090 ( 13 )	6919 ( 28 )	6085 ( 37 )
PF-04518600 Cycle1/Day8-168 H, n=11,11,8,13,23	2669 ( 51 )	9427 ( 25 )	31650 ( 34 )	3131 ( 32 )	2631 ( 28 )
PF-04518600 Cycle1/Day15-1 H/EOI, n=9,10,7,13,19	5969 ( 77 )	27460 ( 24 )	96640 ( 22 )	6697 ( 71 )	7173 ( 35 )
PF-04518600 Cycle2/Day1-1 H/EOI, n=11,8,7,12,23	7776 ( 33 )	31880 ( 16 )	104100 ( 56 )	9212 ( 30 )	7627 ( 25 )
PF-04518600 Cycle4/Day1-1 H/EOI, n=3,0,3,9,12	8792 ( 43 )	88888 ( 88888 )	155000 ( 20 )	11730 ( 61 )	10180 ( 36 )
PF-04518600 Cycle6/Day1-1 H/EOI, n=0.1,0,6,5	88888 ( 88888 )	32000 ( 99999 )	88888 ( 88888 )	14020 ( 27 )	9753 ( 10 )
PF-04518600 Cycle10/Day1-1 H/EOI, n=0,0,0,2,4	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	14060 ( 16 )	10660 ( 18 )

No statistical analyses for this end point

Secondary: Maximum Observed Plasma Concentration (Cmax) of Avelumab and PD 0360324 in Combination C

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End point title

Maximum Observed Plasma Concentration (Cmax) of Avelumab and PD 0360324 in Combination C ^[33]

End point description

End point type

Secondary

End point timeframe

1 hour (i.e. at the end of infusion) post-dose on Day 1,15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Day 1 of Cycle 2, 4, 6 and Cycle 10

Notes
[33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-C Ph-1b PD 0360324 50mg +Avelumab	Com-C Ph-1b PD 0360324 100mg +Avelumab	Com-C Ph-1b PD 0360324 150mg +Avelumab
Number of subjects analysed	10	7	6
Units: Nanogram per milliliter
geometric mean (geometric coefficient of variation)
Avelumab Cycle1/Day1-1 H/EOI, n=9,7,2	217.0 ( 13 )	209.9 ( 34 )	247.9 ( 18 )
Avelumab Cycle1/Day8-168 H, n=9,7,6	53.39 ( 31 )	63.12 ( 25 )	47.89 ( 28 )
Avelumab Cycle1/Day15-1 H/EOI, n=8,7,3	233.8 ( 26 )	277.4 ( 20 )	263.6 ( 33 )
Avelumab Cycle2/Day1-1 H/EOI, n=6,5,3	253.7 ( 15 )	295.2 ( 30 )	254.0 ( 20 )
Avelumab Cycle4/Day1-1 H/EOI, n=2,2,2	242.0 ( 24 )	331.1 ( 29 )	304.8 ( 44 )
Avelumab Cycle6/Day1-1 H/EOI, n=2,2,1	248.2 ( 17 )	292.4 ( 17 )	270.0 ( 99999 )
Avelumab Cycle10/Day1-1 H/EOI, n=0,1,0	88888 ( 88888 )	318.0 ( 99999 )	88888 ( 88888 )
PD 0360324 Cycle1/Day1-30Min/EOI, n=10,5,5	17570 ( 22 )	34420 ( 55 )	38200 ( 44 )
PD 0360324 Cycle1/Day8-168 H, n=9,6,6	1324 ( 109 )	8846 ( 43 )	6598 ( 47 )
PD 0360324 Cycle1/Day15-30 min/EOI, n=9,6,5	16620 ( 27 )	32550 ( 29 )	46130 ( 51 )
PD 0360324 Cycle2/Day1-30 min/EOI, n=8,6,5	17050 ( 20 )	11690 ( 1072 )	57420 ( 16 )
PD 0360324 Cycle4/Day1-30 min/EOI, n=2,2,5	17700 ( 2 )	27060 ( 8 )	43650 ( 51 )
PD 0360324 Cycle6/Day1-30 min/EOI, n=2,2,3	15590 ( 12 )	35140 ( 8 )	58620 ( 27 )
PD 0360324 Cycle10/Day1-30 min/EOI, n=0,1,2	88888 ( 88888 )	33100 ( 99999 )	3216 ( 11668 )

No statistical analyses for this end point

Secondary: Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination D

Top of page

End point title

Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination D ^[34]

End point description

End point type

Secondary

End point timeframe

1 hour post-dose (at end of infusion) on Days 1 and 15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Pre-dose and 1 hour post-dose on Day 1 of Cycle 2, 4, 6, 10

Notes
[34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab
Number of subjects analysed	11	12	12	9	12	10
Units: Nanogram per milliliter
geometric mean (geometric coefficient of variation)
Cycle1/Day1-1 Hour/EOI, n=10,11,12,8,12,10	158.3 ( 26 )	188.2 ( 26 )	200.8 ( 22 )	185.1 ( 38 )	187.4 ( 18 )	174.2 ( 32 )
Cycle1/Day8-168 Hour, n=11,12,12,9,12,9	46.74 ( 46 )	37.71 ( 20 )	39.14 ( 24 )	41.96 ( 24 )	41.32 ( 24 )	36.07 ( 36 )
Cycle1/Day15-1 Hour/EOI, n=11,9,12,5,11,7	201.8 ( 20 )	124.1 ( 136 )	150.8 ( 91 )	167.3 ( 17 )	217.2 ( 20 )	80.14 ( 1114 )
Cycle2/Day1-1 Hour/EOI, n=11,7,11,5,9,7	200.4 ( 18 )	190.9 ( 23 )	149.2 ( 143 )	142.9 ( 42 )	228.5 ( 18 )	175.1 ( 24 )
Cycle4/Day1-1 Hour/EOI, n=3,4,6,3,5,3	188.9 ( 30 )	210.0 ( 23 )	193.9 ( 29 )	192.8 ( 6 )	223.2 ( 16 )	178.7 ( 25 )
Cycle6/Day1-1 Hour/EOI, n=4,4,4,2,2,3	216.7 ( 25 )	198.8 ( 34 )	208.2 ( 13 )	161.0 ( 4 )	217.1 ( 8 )	193.3 ( 19 )
Cycle10/Day1-1 Hour/EOI, n=3,3,3,2,1,2	203.7 ( 10 )	196.0 ( 53 )	194.5 ( 26 )	182.0 ( 2 )	268.0 ( 99999 )	229.1 ( 34 )

No statistical analyses for this end point

Secondary: Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination D

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End point title

Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination D ^[35]

End point description

End point type

Secondary

End point timeframe

1 hour (at end of infusion) post-dose on Day 1 of Cycles 1, 3, 5, 8 and Cycle 12; Days 8 of Cycle 1 (non-dosing)

Notes
[35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab
Number of subjects analysed	12	12	12	11	12	11
Units: Nanogram per milliliter
geometric mean (geometric coefficient of variation)
Cycle1/Day1-1 Hour/EOI, n=12,10,12,11,12,11	3370 ( 39 )	8935 ( 67 )	3751 ( 78 )	4919 ( 104 )	2155 ( 79 )	9567 ( 22 )
Cycle1/Day8-168 Hour, n= 11, 12, 12,9 12,9	1406 ( 44 )	3066 ( 22 )	1043 ( 45 )	2437 ( 85 )	1318 ( 34 )	2940 ( 78 )
Cycle3/Day1-1 Hour/EOI, n=,5,8,6,7,5	2413 ( 14 )	11820 ( 47 )	3953 ( 51 )	9471 ( 46 )	2669 ( 116 )	8877 ( 12 )
Cycle5/Day1-1 Hour/EOI, n=4,5,5,1,4,4	3477 ( 51 )	14310 ( 19 )	2694 ( 123 )	7500 ( 99999 )	2475 ( 56 )	8029 ( 21 )
Cycle8/Day1-1 Hour/EOI, n=2,4,4,2,2,2	2596 ( 8 )	3354 ( 374 )	3202 ( 126 )	14790 ( 24 )	2028 ( 33 )	5542 ( 71 )
Cycle12/Day1-1 Hour/EOI, n=2,4,2,2,1,0	2460 ( 1 )	13400 ( 9 )	3422 ( 51 )	13220 ( 39 )	1120 ( 99999 )	88888 ( 88888 )

No statistical analyses for this end point

Secondary: Maximum Observed Plasma Concentration (Cmax) of PF-04518600 in Combination D

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End point title

Maximum Observed Plasma Concentration (Cmax) of PF-04518600 in Combination D ^[36]

End point description

End point type

Secondary

End point timeframe

1 hour post-infusion (at end of infusion) on Day 1 and 15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Day 1 of Cycle 2, 4, 6 and Cycle 10

Notes
[36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab
Number of subjects analysed	11	12	12	12	12	11
Units: Nanogram per milliliter
geometric mean (geometric coefficient of variation)
Cycle1/Day1-1 H/EOI, n=10,12,11,12,12,11	1698 ( 51 )	1714 ( 24 )	5224 ( 58 )	4417 ( 59 )	18250 ( 30 )	17770 ( 33 )
Cycle1/Day8-168 H, n=11,12,12,9,12,8	695.1 ( 26 )	589.5 ( 41 )	2379 ( 30 )	2139 ( 31 )	9717 ( 15 )	7700 ( 35 )
Cycle1/Day15-1 H/EOI, n=11,11,12,8,12,7	1841 ( 65 )	1823 ( 35 )	6595 ( 26 )	8559 ( 68 )	24470 ( 23 )	23330 ( 22 )
Cycle2/Day1-1 H/EOI, n=8,8,11,7,8,7	2278 ( 24 )	1901 ( 22 )	7497 ( 39 )	7373 ( 18 )	25890 ( 50 )	25180 ( 29 )
Cycle4/Day1-1 H/EOI, n=5,5,5,3,7,3	2711 ( 44 )	2453 ( 34 )	9984 ( 39 )	7279 ( 29 )	36930 ( 14 )	39590 ( 26 )
Cycle6/Day1-1 H/EOI, n=4,5,3,2,4,3	2633 ( 27 )	2704 ( 26 )	13340 ( 27 )	6637 ( 20 )	34540 ( 24 )	36190 ( 20 )
Cycle10/Day1-1 H/EOI, n=3,4,4,2,2,2	2741 ( 20 )	2685 ( 50 )	11130 ( 44 )	9026 ( 61 )	44170 ( 16 )	39190 ( 43 )

No statistical analyses for this end point

Secondary: Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination F

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End point title

Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination F ^[37]

End point description

End point type

Secondary

End point timeframe

1-hour post-infusion (i.e. at the end of infusion) on Days 1 and 15 of Cycle 1 (non-dosing); Day 1 of Cycles 2, 4, 6 and Cycle 10

Notes
[37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-F Ph-1b SCCHN CMP-001 10mg +Avelumab	Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg	Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg
Number of subjects analysed	6	6	6
Units: Nanogram per milliliter
geometric mean (geometric coefficient of variation)
Cycle1/Day1-1 Hour/EOI, n=6,5,6	161.2 ( 14 )	166.1 ( 15 )	180.7 ( 49 )
Cycle1/Day15-1 Hour/EOI, n=5,6,5	182.6 ( 11 )	171.2 ( 27 )	151.6 ( 16 )
Cycle2/Day1-1 Hour/EOI, n=5,5,4	165.5 ( 10 )	176.7 ( 22 )	171.0 ( 26 )
Cycle4/Day1-1 Hour/EOI, n=2,3,0	185.0 ( 24 )	203.9 ( 27 )	88888 ( 88888 )
Cycle6/Day1-1 Hour/EOI, n=1,1,0	229.0 ( 99999 )	174.0 ( 99999 )	88888 ( 88888 )
Cycle10/Day1-1 Hour/EOI, n=1,0,0	191.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )

No statistical analyses for this end point

Secondary: Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination A

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End point title

Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination A ^[38]

End point description

Ctrough is steady-state pre-dose concentration. PK analysis set included all subjects who received at least one dose of study drug and who had at least one of the PK concentrations for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of subjects analyzed’’ signifies number of subjects evaluable for this endpoint, where “Number Analyzed” signifies number of subjects evaluable for specified time points. For ‘’Phase 2 1L NSCLC: Utomilumab then Utomilumab + Avelumab’’ reporting group PK sampling started from Cycle 2 Day 1. 99999 indicates Only 1 observation was equal or above lower limit of quantification (LLoQ). Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated. 88888 indicates there were >2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.

End point type

Secondary

End point timeframe

Pre-dose on Days 1 and 15 of Cycle 1, Day 8 of Cycle 1 (non-dosing) and then Day 1 of Cycles 2,4,6 and Cycle 10. For ‘’Phase 2 1L NSCLC: Utomilumab then Utomilumab + Avelumab’’ reporting group: Day 1 of Cycles 2,4,6,10

Notes
[38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab	Com-A Ph-2 Melanoma Utomilumab 100mg+Avelumab	Com-A Ph-2 SCCHN Utomilumab 100mg+Avelumab	Com-A Ph-2 TNBC Utomilumab 100mg+Avelumab	Com-A Ph-2 SCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1st line(1L) NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab	Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab
Number of subjects analysed	27	27	29	27	33	20	9	20	9	11
Units: Nanogram per milliliter
geometric mean (geometric coefficient of variation)
Cycle1/Day1-0 Hour, n=27,26,29,27,33,20,9,20,0,11	9.510 ( 99999 )	5.532 ( 540 )	16.24 ( 19873078 )	64.96 ( 162 )	93.02 ( 190 )	88888 ( 88888 )	9.440 ( 99999 )	3.082 ( 80 )	88888 ( 88888 )	88888 ( 88888 )
Cycle1/Day15-0 Hour, n=23,24,28,26,29,19,8,17,0,11	22.13 ( 106 )	17.85 ( 135 )	19.92 ( 102 )	22.02 ( 138 )	23.03 ( 74 )	25.53 ( 38 )	18.37 ( 53 )	13.15 ( 45 )	88888 ( 88888 )	9.781 ( 84 )
Cycle2/Day1-0 Hour, n=22,22,22,24,29,17,5,17,9,10	23.14 ( 84 )	20.69 ( 115 )	22.67 ( 105 )	25.45 ( 224 )	23.35 ( 77 )	27.94 ( 43 )	21.61 ( 76 )	12.52 ( 80 )	88888 ( 88888 )	10.96 ( 110 )
Cycle4/Day1-0 Hour, n=14,8,11,10,15.9.3,6,8,6	18.79 ( 132 )	21.53 ( 103 )	32.46 ( 74 )	49.20 ( 259 )	23.30 ( 59 )	26.82 ( 55 )	20.21 ( 86 )	26.50 ( 85 )	10.52 ( 140 )	15.38 ( 81 )
Cycle6/Day1-0 Hour, n=10,4,6,5,11,7,2,5,6,6	24.80 ( 52 )	27.33 ( 99 )	33.45 ( 40 )	59.47 ( 105 )	24.28 ( 65 )	26.17 ( 57 )	20.66 ( 9 )	27.62 ( 73 )	22.16 ( 43 )	21.05 ( 45 )
Cycle10/Day1-0 Hour, n=7,3,4,4,5,3,0,3,2,4	27.56 ( 46 )	26.87 ( 100 )	40.42 ( 66 )	39.89 ( 24 )	34.09 ( 52 )	25.31 ( 101 )	88888 ( 88888 )	34.90 ( 47 )	19.04 ( 117 )	19.41 ( 24 )

No statistical analyses for this end point

Secondary: Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination A

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End point title

Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination A ^[39]

End point description

Ctrough is steady-state pre-dose concentration. PK analysis set included all subjects who received at least one dose of study drug and who had at least one of the PK concentrations for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of subjects analyzed’’ signifies number of subjects evaluable for this endpoint, where “Number Analyzed” signifies number of subjects evaluable for specified time points. For subjects of ‘’Phase 2 1L NSCLC: Avelumab then Utomilumab + Avelumab’’ reporting group PK sampling started from Cycle 3 Day 1. 99999 indicates Only 1 observation was equal or above lower limit of quantification (LLoQ). Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated. 88888 indicates there were >2 observations, and no observation was equal or above LLoQ.

End point type

Secondary

End point timeframe

Pre-dose on Day 1 of Cycles 1,3,5,8, and Cycle 12; Days 8 and 15 of Cycle 1 (non-dosing). For ‘’Phase 2 1L NSCLC: Avelumab then Utomilumab + Avelumab’’ reporting group: Day 1 of Cycles 3,5,8 and 12

Notes
[39] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab	Com-A Ph-2 Melanoma Utomilumab 100mg+Avelumab	Com-A Ph-2 SCCHN Utomilumab 100mg+Avelumab	Com-A Ph-2 TNBC Utomilumab 100mg+Avelumab	Com-A Ph-2 SCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1st line(1L) NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab	Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab
Number of subjects analysed	28	27	29	28	33	21	10	20	10	8
Units: Nanogram per milliliter
geometric mean (geometric coefficient of variation)
Cycle1/Day1-0 Hour, n=28,27,29,28,33,21,10,20,10,0	619.0 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	1430 ( 99999 )	931.0 ( 99999 )	88888 ( 88888 )	20500 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
Cycle1/Day15-0 Hour, n=26,22,29,26,32,21,8,18,9,0	2723 ( 28 )	1536 ( 26 )	779.3 ( 25 )	1443 ( 20 )	1688 ( 23 )	2323 ( 30 )	2509 ( 28 )	2529 ( 49 )	99999 ( 42 )	88888 ( 88888 )
Cycle3/Day1-0 Hour, n=17,12,21,14,18,10,3,10,8,8	2114 ( 30 )	982.3 ( 29 )	743.2 ( 26 )	1627 ( 145 )	1547 ( 72 )	1351 ( 38 )	693.5 ( 29 )	1114 ( 38 )	99999 ( 69 )	780.4 ( 48 )
Cycle5/Day1-0 Hour, n=10,6,7,8,15,8,3,5,6,7	2259 ( 53 )	1059 ( 63 )	931.9 ( 97 )	1281 ( 33 )	1366 ( 37 )	1417 ( 25 )	855.1 ( 14 )	1046 ( 30 )	906.7 ( 67 )	671.9 ( 38 )
Cycle8/Day1-0 Hour, n=7,5,4,5,6,5,2,22,6,6	1840 ( 54 )	1726 ( 21 )	839.9 ( 38 )	1747 ( 19 )	2300 ( 138 )	1196 ( 29 )	1030 ( 99999 )	1070 ( 99999 )	669.0 ( 27 )	851.8 ( 30 )
Cycle12/Day1-0 Hour, n=6,3,4,5,2,3,0,1,3,3	1814 ( 52 )	1171 ( 24 )	690.2 ( 35 )	1172 ( 39 )	610.0 ( 99999 )	1359 ( 5 )	88888 ( 88888 )	88888 ( 88888 )	655.4 ( 64 )	653.9 ( 23 )

No statistical analyses for this end point

Secondary: Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PF-04518600 in Combination B

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End point title

Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PF-04518600 in Combination B ^[40]

End point description

Ctrough is steady-state pre-dose concentration. PK analysis set included all subjects who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of subjects analyzed’’ signifies number of subjects evaluable for this endpoint, where “Number Analyzed” signifies number of subjects evaluable for specified time points. 99999 indicates Only 1 observation was equal or above lower limit of quantification (LLoQ). Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated. 88888 indicates there were >2 observations, and no observation was equal or above LLoQ.

End point type

Secondary

End point timeframe

Pre-dose on Days 1 and 15 of Cycle 1, Day 8 of Cycle 1 (non-dosing); Day 1 of Cycles 2, 4, 6 and Cycle 10

Notes
[40] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-B Ph-1b PF-04518600 0.3mg/kg +Avelumab	Com-B Ph-1b PF-04518600 1.0 mg/kg +Avelumab	Com-B Ph-1b PF-04518600 3.0 mg/kg +Avelumab	Com-B Ph-2 NSCLC PF-04518600 0.3 mg/kg +Avelumab	Com-B Ph-2 SCCHN PF-04518600 0.3 mg/kg +Avelumab
Number of subjects analysed	12	12	8	14	25
Units: Nanogram per milliliter
geometric mean (geometric coefficient of variation)
Avelumab Cycle1/Day1-0 Hour, n=12,12,8,14,25	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	228.0 ( 99999 )	88888 ( 88888 )
Avelumab Cycle1/Day15-0 Hour, n=10,11,6,13,22	19.05 ( 69 )	16.83 ( 63 )	19.88 ( 50 )	21.72 ( 54 )	17.00 ( 63 )
Avelumab Cycle2/Day1-0 Hour, n=10,8,6,12,18	21.10 ( 84 )	21.27 ( 47 )	22.04 ( 70 )	25.32 ( 59 )	18.77 ( 92 )
Avelumab Cycle4/Day1-0 Hour, n=2,2,2,10,13	15.72 ( 179 )	21.16 ( 13 )	22.37 ( 91 )	22.69 ( 46 )	17.95 ( 90 )
Avelumab Cycle6/Day1-0 Hour, n=0,1,0,5,6	88888 ( 88888 )	16.00 ( 99999 )	88888 ( 88888 )	29.83 ( 34 )	25.82 ( 37 )
Avelumab Cycle10/Day1-0 Hour, n=0,0,0,1,3	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	26.30 ( 99999 )	23.70 ( 24 )
PF-04518600 Cycle1/Day1-0 Hour, n=12,12,8,13,25	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	5750 ( 99999 )	23.10 ( 99999 )
PF-04518600 Cycle1/Day15-0 Hour, n=10,11,6,13,22	1497 ( 55 )	6234 ( 50 )	25320 ( 29 )	1758 ( 59 )	1702 ( 50 )
PF-04518600 Cycle2/Day1-0 Hour, n=11,8,7,13,23	1826 ( 176 )	11000 ( 23 )	31830 ( 99 )	2928 ( 39 )	2327 ( 58 )
PF-04518600 Cycle4/Day1-0 Hour, n= 3,1,3,10,13	2324 ( 235 )	88888 ( 88888 )	79790 ( 28 )	4799 ( 47 )	5129 ( 43 )
PF-04518600 Cycle6/Day1-0 Hour, n=0,1,0,6,6	88888 ( 88888 )	17200 ( 99999 )	88888 ( 88888 )	6577 ( 37 )	6508 ( 23 )
PF-04518600 Cycle10/Day1-0 Hour, n=0,0,0,2,4	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	8097 ( 59 )	5484 ( 16 )

No statistical analyses for this end point

Secondary: Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PD 0360324 in Combination C

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End point title

Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PD 0360324 in Combination C ^[41]

End point description

End point type

Secondary

End point timeframe

Pre-dose on Days 1 and 15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Pre-dose and 0 hour post-dose on Day 1 of Cycles 2, 4, 6 and Cycle 10

Notes
[41] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-C Ph-1b PD 0360324 50mg +Avelumab	Com-C Ph-1b PD 0360324 100mg +Avelumab	Com-C Ph-1b PD 0360324 150mg +Avelumab
Number of subjects analysed	10	8	6
Units: Nanogram per milliliter
geometric mean (geometric coefficient of variation)
Avelumab Cycle1/Day1-0 Hour, n=10,8,6	0.2090 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )
Avelumab Cycle1/Day15-0 Hour, n=9,8,6	20.45 ( 39 )	32.34 ( 40 )	22.53 ( 63 )
Avelumab Cycle2/Day1-0 Hour, n=8,6,5	16.35 ( 136 )	31.44 ( 98 )	15.94 ( 237 )
Avelumab Cycle4/Day1-0 Hour, n=2,2,5	15.50 ( 23 )	57.13 ( 80 )	36.04 ( 37 )
Avelumab Cycle6/Day1-0 Hour, n=2,1,2	26.38 ( 24 )	77.20 ( 99999 )	33.23 ( 15 )
Avelumab Cycle10/Day1-0 Hour, n=0,1,2	88888 ( 88888 )	46.90 ( 99999 )	27.09 ( 4 )
PD 0360324 Cycle1/Day1-0 Hour, n=10,7,6	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
PD 0360324 Cycle1/Day15-0 Hour, n=9,6,6	126.2 ( 20 )	390.9 ( 94 )	583.1 ( 101 )
PD 0360324 Cycle2/Day1-0 Hour, n=8,6,5	137.7 ( 46 )	360.4 ( 110 )	2987 ( 105 )
PD 0360324 Cycle4/Day1-0 Hour, n=2,2,5	88888 ( 88888 )	447.2 ( 62 )	1397 ( 190 )
PD 0360324 Cycle6/Day1-0 Hour, n=2,2,3	134.0 ( 99999 )	654.0 ( 99999 )	312.1 ( 128 )
PD 0360324 Cycle10/Day1-0 Hour, n=0,1,1	88888 ( 88888 )	115.0 ( 99999 )	169.0 ( 99999 )

No statistical analyses for this end point

Secondary: Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination D

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End point title

Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination D ^[42]

End point description

End point type

Secondary

End point timeframe

Pre-dose on Day 1 of Cycle 1, 2, 4, 6 and Cycle 10; Day 15 of Cycle 1 (non-dosing)

Notes
[42] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab
Number of subjects analysed	11	12	12	12	12	11
Units: Nanogram per milliliter
geometric mean (geometric coefficient of variation)
Cycle1/Day1-0 Hour, n=11,12,12,12,12,11	6.200 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
Cycle1/Day15-0 Hour, n=11,11,12,8,12,7	17.61 ( 54 )	13.22 ( 35 )	13.48 ( 38 )	17.52 ( 16 )	14.42 ( 78 )	9.445 ( 102 )
Cycle2/Day1-0 Hour, n=11,10,11,7,10,7	16.04 ( 116 )	11.04 ( 178 )	17.23 ( 31 )	11.93 ( 95 )	22.29 ( 32 )	13.19 ( 94 )
Cycle4/Day1-0 Hour, n=5,5,6,3,7,3	26.76 ( 69 )	31.10 ( 54 )	17.77 ( 27 )	24.73 ( 20 )	29.11 ( 32 )	27.00 ( 10 )
Cycle6/Day1-0 Hour, n=4,5,4,2,3,2	30.03 ( 52 )	31.36 ( 59 )	18.87 ( 17 )	27.05 ( 1 )	33.12 ( 36 )	25.26 ( 8 )
Cycle10/Day1-0 Hour, n=3,4,4,2,2,2	32.84 ( 48 )	36.98 ( 32 )	18.39 ( 26 )	35.08 ( 14 )	26.33 ( 29 )	39.35 ( 28 )

No statistical analyses for this end point

Secondary: Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination D

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End point title

Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination D ^[43]

End point description

End point type

Secondary

End point timeframe

Pre-dose on Day 1 of Cycle 1, 3, 5, 8 and Cycle 12; Day 15 of Cycle 1 (non-dosing)

Notes
[43] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab
Number of subjects analysed	11	11	12	12	12	11
Units: Nanogram per milliliter
geometric mean (geometric coefficient of variation)
Cycle1/Day1-0 Hour, n=11,11,11,12,12,11	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
Cycle1/Day15-0 Hour, n=9,10,10,9,12,9	616.5 ( 41 )	1353 ( 24 )	726.4 ( 19 )	1649 ( 34 )	595.2 ( 23 )	1752 ( 16 )
Cycle3/Day1-0 Hour, n=5,5,8,6,6,5	561.0 ( 99999 )	846.0 ( 54 )	516.6 ( 31 )	602.2 ( 38 )	813.3 ( 28 )	88888 ( 88888 )
Cycle5/Day1-0 Hour, n=4,5,6,2,4,4	712.3 ( 11 )	718.1 ( 34 )	505.0 ( 23 )	422.0 ( 99999 )	763.0 ( 99999 )	88888 ( 88888 )
Cycle8/Day1-0 Hour, n=2,4,4,2,3,2	88888 ( 88888 )	730.5 ( 23 )	674.3 ( 41 )	1440 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )
Cycle12/Day1-0 Hour, n=2,4,3,2,1,0	407.0 ( 99999 )	720.9 ( 25 )	794.2 ( 105 )	985.6 ( 81 )	88888 ( 88888 )	88888 ( 88888 )

No statistical analyses for this end point

Secondary: Pre-Dose Observed Plasma Concentration (Ctrough) of PF-04518600 in Combination D

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End point title

Pre-Dose Observed Plasma Concentration (Ctrough) of PF-04518600 in Combination D ^[44]

End point description

Ctrough is steady-state pre-dose concentration. PK analysis set included all subjects who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of subjects analyzed’’ signifies number of subjects evaluable for this endpoint, where “Number Analyzed” signifies number of subjects evaluable for specified time points. 88888 indicates there were >2 observations, and no observation was equal or above LLoQ.

End point type

Secondary

End point timeframe

Pre-dose on Days 1 and 15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Pre-dose on Day 1 of Cycles 2, 4, 6 and Cycle 10

Notes
[44] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab
Number of subjects analysed	11	11	12	11	12	11
Units: Nanogram per milliliter
geometric mean (geometric coefficient of variation)
Cycle1/Day1-0 Hour, n=10,11,12,11,12,11	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )	88888 ( 88888 )
Cycle1/Day15-0 Hour, n=11,11,12,8,12,9	320.2 ( 86 )	144.2 ( 128 )	1342 ( 50 )	1529 ( 31 )	6388 ( 22 )	5466 ( 30 )
Cycle2/Day1-0 Hour, n=11,11,11,7,10,7	426.0 ( 48 )	192.6 ( 168 )	1823 ( 121 )	2164 ( 31 )	11470 ( 19 )	8241 ( 86 )
Cycle4/Day1-0 Hour, n=5,5,6,3,7,3	891.8 ( 60 )	656.8 ( 101 )	4524 ( 32 )	3506 ( 38 )	24010 ( 16 )	21500 ( 12 )
Cycle6/Day1-0 Hour, n=4,5,4,2,4,3	1033 ( 84 )	793.4 ( 110 )	6712 ( 22 )	3971 ( 17 )	21990 ( 56 )	20230 ( 18 )
Cycle10/Day1-0 Hour, n=3,4,4,2,2,2	1444 ( 25 )	829.8 ( 181 )	6900 ( 65 )	4834 ( 76 )	24880 ( 19 )	22620 ( 30 )

No statistical analyses for this end point

Secondary: Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination F

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End point title

Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination F ^[45]

End point description

End point type

Secondary

End point timeframe

Pre-dose on Days 1 and 15 of Cycle 1 (non-dosing); Pre-dose on Day 1 of Cycles 2, 4, 6 and Cycle 10

Notes
[45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-F Ph-1b SCCHN CMP-001 10mg +Avelumab	Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg	Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg
Number of subjects analysed	6	7	6
Units: Nanogram per milliliter
geometric mean (geometric coefficient of variation)
Cycle1/Day1-0 Hour, n=6,7,6	88888 ( 88888 )	88888 ( 88888 )	14.30 ( 99999 )
Cycle1/Day15-0 Hour, n=5,5,6	16.32 ( 71 )	21.26 ( 18 )	18.53 ( 68 )
Cycle2/Day1-0 Hour, n=5,5,5	10.97 ( 137 )	16.76 ( 122 )	18.17 ( 130 )
Cycle4/Day1-0 Hour, n=2,3,1	40.90 ( 20 )	24.36 ( 69 )	88888 ( 88888 )
Cycle6/Day1-0 Hour, n=1,1,0	37.00 ( 99999 )	31.90 ( 99999 )	88888 ( 88888 )
Cycle10/Day1-0 Hour, n=1,1,0	30.40 ( 99999 )	88888 ( 88888 )	88888 ( 88888 )

No statistical analyses for this end point

Secondary: Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination F

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End point title

Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination F ^[46]

End point description

End point type

Secondary

End point timeframe

Pre-dose on Day 1 of Cycle 1 (non-dosing); Pre-dose on Day 1 of Cycles 2 and 4

Notes
[46] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg
Number of subjects analysed	7
Units: Nanogram per milliliter
geometric mean (geometric coefficient of variation)
Cycle1/Day1-0 Hour, n=0,7,0	88888 ( 88888 )
Cycle2/Day1-0 Hour, n=0,6,0	748.9 ( 25 )
Cycle4/Day1-0 Hour, n=0,3,0	866.0 ( 99999 )

No statistical analyses for this end point

Secondary: Number of Subjects With Positive Anti-Drug Antibody (ADA) Against Avelumab For Combination A

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End point title

Number of Subjects With Positive Anti-Drug Antibody (ADA) Against Avelumab For Combination A ^[47]

End point description

ADA ever-positive was defined as at least one positive ADA result at any time point. Baseline is defined as the last assessment on or prior to the date/time of the first dose of avelumab. The analysis population was a subset of the safety analysis set (all subjects who received at least one dose of study drug) and included subjects who had at least one ADA sample collected for avelumab. The combined arm during Phase 1b/2 subjects with NSCLC, Melanoma, SCCHN, TNBC and SCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks combined based on dose level.

End point type

Secondary

End point timeframe

Pre-dose on Day 1 of Cycle 1, 2, 4, 6, 10. For ‘’Phase 2 1L NSCLC: Utomilumab then Utomilumab + Avelumab’’ reporting group: Day 1 of Cycle 2, 4, 6, 10

Notes
[47] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab	Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab	Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab	Com-A Ph- 1b/2 Utomilumab 100 mg + Avelumab
Number of subjects analysed	29	29	11	11	141
Units: Subjects	3	2	1	0	13

No statistical analyses for this end point

Secondary: Number of Subjects With Positive ADA Levels Against Utomilumab For Combination A

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End point title

Number of Subjects With Positive ADA Levels Against Utomilumab For Combination A ^[48]

End point description

End point type

Secondary

End point timeframe

Pre-dose on Day 1 of Cycle 1, 3, 5, 8, 12. For ‘’Phase 2 1L NSCLC: Avelumab then Utomilumab + Avelumab’’ reporting group: Day 1 of Cycle 3, 5, 8, 12

Notes
[48] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab	Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab	Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab	Com-A Ph- 1b/2 Utomilumab 100 mg + Avelumab
Number of subjects analysed	29	29	10	9	141
Units: Subjects	6	16	7	6	51

No statistical analyses for this end point

Secondary: Pre-Dose Observed Plasma Concentration (Ctrough) of PF-04518600 in Combination F

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End point title

Pre-Dose Observed Plasma Concentration (Ctrough) of PF-04518600 in Combination F ^[49]

End point description

End point type

Secondary

End point timeframe

Pre-dose on Day 1 of Cycle 1 (non-dosing); Pre-dose on Day 1 of Cycles 2 and 4

Notes
[49] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg
Number of subjects analysed	6
Units: Nanogram per milliliter
geometric mean (geometric coefficient of variation)
Cycle1/Day1-0 Hour, n=0,0,6	88888 ( 88888 )
Cycle2/Day1-0 Hour, n=0,0,5	2179 ( 30 )
Cycle4/Day1-0 Hour, n=0,0,1	3610 ( 99999 )

No statistical analyses for this end point

Secondary: Number of Subjects With Positive ADA Levels For Combination C

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End point title

Number of Subjects With Positive ADA Levels For Combination C ^[50]

End point description

End point type

Secondary

End point timeframe

Pre-dose on Day 1 of Cycle 1, 2, 4, 6, and 10

Notes
[50] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-C Ph-1b PD 0360324 50mg +Avelumab	Com-C Ph-1b PD 0360324 100mg +Avelumab	Com-C Ph-1b PD 0360324 150mg +Avelumab
Number of subjects analysed	10	8	6
Units: Subjects
ADA ever-positive -Avelumab	1	0	0
ADA ever-positive -PD 0360324	0	5	5

No statistical analyses for this end point

Secondary: Number of Subjects With Positive ADA Levels For Combination B

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End point title

Number of Subjects With Positive ADA Levels For Combination B ^[51]

End point description

ADA ever-positive was defined as at least one positive ADA result at any time point. Baseline is defined as the last assessment on or prior to the date/time of the first dose of avelumab. The analysis population was a subset of the safety analysis set (all subjects who received at least one dose of study drug) and included subjects who had at least one ADA sample collected for avelumab. The combined arm during Phase 1b subjects received PF- 04518600 0.3 mg/kg and in phase 2 participants with NSCLC and SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks combined based on dose level.

End point type

Secondary

End point timeframe

Pre-dose on Day 1 of Cycle 1, 2, 4, 6, and 10

Notes
[51] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-B Ph-1b PF-04518600 1.0 mg/kg +Avelumab	Com-B Ph-1b PF-04518600 3.0 mg/kg +Avelumab	Com-B Ph-1b/2 PF-04518600 + Avelumab
Number of subjects analysed	12	8	51
Units: Subjects
ADA ever-positive -Avelumab	0	0	2
ADA ever-positive - PF-04518600	2	1	19

No statistical analyses for this end point

Secondary: Number of Subjects With Positive ADA Levels Against Avelumab and PF-04518600 For Combination D

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End point title

Number of Subjects With Positive ADA Levels Against Avelumab and PF-04518600 For Combination D ^[52]

End point description

End point type

Secondary

End point timeframe

Pre-dose on Day 1 of Cycle 1, 2, 4, 6, and 10

Notes
[52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab
Number of subjects analysed	12	12	12	12	12	11
Units: Subjects
ADA ever-positive -Avelumab	1	1	0	0	0	2
ADA ever-positive -PF-04518600	5	7	6	2	3	1

No statistical analyses for this end point

Secondary: Number of Subjects With Positive ADA Levels Against Utomilumab For Combination D

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End point title

Number of Subjects With Positive ADA Levels Against Utomilumab For Combination D ^[53]

End point description

End point type

Secondary

End point timeframe

Pre-dose on Day 1 of Cycle 1, 3, 5, 8, 12

Notes
[53] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab
Number of subjects analysed	12	12	12	12	12	11
Units: Subjects	3	4	7	5	5	5

No statistical analyses for this end point

Secondary: Number of Subjects With Positive ADA Levels Against Avelumab and PF-04518600 For Combination F

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End point title

Number of Subjects With Positive ADA Levels Against Avelumab and PF-04518600 For Combination F ^[54]

End point description

End point type

Secondary

End point timeframe

Pre-dose on Day 1 of Cycle 1, 2, 4, 6, and 10

Notes
[54] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-F Ph-1b SCCHN CMP-001 10mg +Avelumab	Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg	Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg
Number of subjects analysed	6	7	7
Units: Subjects
ADA ever-positive -Avelumab	0	3	0
ADA ever-positive - PF-04518600	0	0	2

No statistical analyses for this end point

Secondary: Number of Subjects With Positive ADA Levels Against Utomilumab For Combination F

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End point title

Number of Subjects With Positive ADA Levels Against Utomilumab For Combination F ^[55]

End point description

End point type

Secondary

End point timeframe

Pre-dose on Day 1 of Cycle 1, 2, 4, 6, and 10

Notes
[55] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg
Number of subjects analysed	7
Units: Subjects	5

No statistical analyses for this end point

Secondary: Time to Tumor Response (TTR) for Combination A

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End point title

Time to Tumor Response (TTR) for Combination A ^[56]

End point description

TTR was defined for participants with an objective response (confirmed CR or PR) as the time from the start date (the date of first dose of treatment) to the first documentation of objective response (CR or PR) which was subsequently confirmed. Per RECIST v1.1: CR: disappearance of all non-nodal target lesions and of all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions/ non-target lesions must have reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters. Analysis population:all subjects who received at least one dose of study drug and who had confirmed CR or PR. Subjects were classified according to study treatment actually received. If subject received more than one treatment, subject was classified according to first treatment received. 'Number of subjects analyzed' signifies subjects evaluable for this endpoint with at least 1 confirmed CR or PR.

End point type

Secondary

End point timeframe

From first dose of study drug until first documentation of CR or PR (maximum up to 6.5 years)

Notes
[56] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab	Com-A Ph-2 Melanoma Utomilumab 100mg+Avelumab	Com-A Ph-2 SCCHN Utomilumab 100mg+Avelumab	Com-A Ph-2 TNBC Utomilumab 100mg+Avelumab	Com-A Ph-2 SCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1st line(1L) NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab	Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab
Number of subjects analysed	1	0 ^[57]	3	3	3	3	1	1	6	2
Units: Months
median (full range (min-max))	3.6 (3.6 to 3.6)	( to )	1.9 (1.7 to 11.3)	1.9 (1.8 to 7.4)	1.8 (1.5 to 3.5)	1.7 (1.6 to 1.7)	1.7 (1.7 to 1.7)	1.6 (1.6 to 1.6)	3.7 (1.8 to 7.4)	2.7 (1.6 to 3.7)

Notes
[57] - No subjects were analyzed for this reporting group.

No statistical analyses for this end point

Secondary: TTR for Combination B

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End point title

TTR for Combination B ^[58]

End point description

TTR was defined for participants with an objective response (confirmed CR or PR) as the time from the start date (the date of first dose of treatment) to the first documentation of objective response (CR or PR) which was subsequently confirmed. Per RECIST v1.1: CR: disappearance of all non-nodal target lesions and of all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions/ non-target lesions must have reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters. Analysis population: all subjects who received at least one dose of study drug and who had confirmed CR or PR. Subjects were classified according to study treatment actually received. If subject received more than one treatment, subject was classified according to first treatment received. 'Number of subjects analyzed' signifies subjects evaluable for this endpoint with at least 1 confirmed CR or PR.

End point type

Secondary

End point timeframe

From first dose of study drug until first documentation of CR or PR (maximum up to 3.5 years)

Notes
[58] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-B Ph-1b PF-04518600 0.3mg/kg +Avelumab	Com-B Ph-1b PF-04518600 1.0 mg/kg +Avelumab	Com-B Ph-1b PF-04518600 3.0 mg/kg +Avelumab	Com-B Ph-2 NSCLC PF-04518600 0.3 mg/kg +Avelumab	Com-B Ph-2 SCCHN PF-04518600 0.3 mg/kg +Avelumab
Number of subjects analysed	0 ^[59]	0 ^[60]	0 ^[61]	2	2
Units: Months
median (full range (min-max))	( to )	( to )	( to )	2.8 (1.9 to 3.7)	3.6 (1.7 to 5.6)

Notes
[59] - No subjects were analyzed for this reporting group.
[60] - No subjects were analyzed for this reporting group.
[61] - No subjects were analyzed for this reporting group.

No statistical analyses for this end point

Secondary: TTR for Combination F

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End point title

TTR for Combination F ^[62]

End point description

TTR was defined, for participants with an objective response (confirmed CR or PR), as the time from the start date (the date of first dose of treatment) to the first documentation of objective response (CR or PR) which was subsequently confirmed. Per RECIST v1.1: CR: disappearance of all non-nodal target lesions and of all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions/ non-target lesions must have reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters. Analysis population:all subjects who received at least one dose of study drug and who had confirmed CR or PR. Subjects were classified according to study treatment actually received. If subject received more than one treatment, subject was classified according to first treatment received. 'Number of subjects analyzed' signifies subjects evaluable for this endpoint with at least 1 confirmed CR or PR.

End point type

Secondary

End point timeframe

From first dose of study drug until first documentation of CR or PR (maximum up to 3 years)

Notes
[62] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-F Ph-1b SCCHN CMP-001 10mg +Avelumab	Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg	Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg
Number of subjects analysed	0 ^[63]	1	0 ^[64]
Units: Months
median (full range (min-max))	( to )	4.4 (4.4 to 4.4)	( to )

Notes
[63] - No subjects were analyzed for this reporting group.
[64] - No subjects were analyzed for this reporting group.

No statistical analyses for this end point

Secondary: TTR for Combination D

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End point title

TTR for Combination D ^[65]

End point description

End point type

Secondary

End point timeframe

From first dose of study drug until first documentation of CR or PR (maximum up to 4.5 years)

Notes
[65] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab
Number of subjects analysed	1	4	3	1	1	2
Units: Months
median (full range (min-max))	3.7 (3.7 to 3.7)	1.7 (1.7 to 3.7)	1.6 (1.6 to 1.7)	1.8 (1.8 to 1.8)	1.8 (1.8 to 1.8)	2.8 (1.9 to 3.7)

No statistical analyses for this end point

Secondary: TTR for Combination C

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End point title

TTR for Combination C ^[66]

End point description

End point type

Secondary

End point timeframe

From first dose of study drug until first documentation of CR or PR (maximum up to 1.8 years)

Notes
[66] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-C Ph-1b PD 0360324 50mg +Avelumab	Com-C Ph-1b PD 0360324 100mg +Avelumab	Com-C Ph-1b PD 0360324 150mg +Avelumab
Number of subjects analysed	1	2	1
Units: Months
median (full range (min-max))	4.0 (4.0 to 4.0)	2.8 (2.2 to 3.5)	9.4 (9.4 to 9.4)

No statistical analyses for this end point

Secondary: Duration of Response (DR) for Combination A

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End point title

Duration of Response (DR) for Combination A ^[67]

End point description

DR assessed by investigator per RECIST v1.1, DR=date of first documented OR (CR or PR) to date of PD or death due to any cause, or data censoring date, whichever occurred first. CR: disappearance of all target and non-target lesions and sustained for at least 4 week. Any pathological lymph nodes (target/non-target) reduced in short axis to <10 mm. PR: >= 30% decrease in sum of diameter of target lesion taking as reference baseline sum diameter. PD: >=20% increase in sum of diameter of target lesion, taking as reference smallest sum on study treatment, with absolute increase of at least 5 mm or appearance of >=1 new lesion. DR data was censored on date of last adequate tumor assessment for subjects with CR, PR, PD or death, for subjects who start new anti-cancer treatment prior to DR assessment, for subjects with DR assessment after >=2 missing tumor assessments. FAS: all subjects who received at least one dose of study drug. “Overall Number of Subjects Analyzed” =subjects evaluable

End point type

Secondary

End point timeframe

From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum up to 6.5 years)

Notes
[67] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab	Com-A Ph-2 Melanoma Utomilumab 100mg+Avelumab	Com-A Ph-2 SCCHN Utomilumab 100mg+Avelumab	Com-A Ph-2 TNBC Utomilumab 100mg+Avelumab	Com-A Ph-2 SCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1st line(1L) NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab	Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab
Number of subjects analysed	1	0 ^[68]	3	3	3	3	1	1	6	2
Units: Months
median (full range (min-max))	12.5 (12.5 to 12.5)	( to )	27.4 (20.9 to 33.9)	52.9 (7.9 to 53.2)	15.8 (5.7 to 29.5)	28.5 (3.8 to 29.7)	3.7 (3.7 to 3.7)	4.9 (4.9 to 4.9)	8.1 (2.5 to 43.1)	24.8 (5.6 to 44.0)

Notes
[68] - No subjects were analyzed for this reporting group.

No statistical analyses for this end point

Secondary: DR for Combination D

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End point title

DR for Combination D ^[69]

End point description

End point type

Secondary

End point timeframe

From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum up to 4.5 years)

Notes
[69] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab
Number of subjects analysed	1	4	3	1	1	2
Units: Months
median (full range (min-max))	5.5 (5.5 to 5.5)	28.5 (17.5 to 49.0)	22.1 (17.8 to 35.3)	38.6 (38.6 to 38.6)	26.3 (26.3 to 26.3)	7.4 (5.6 to 9.3)

No statistical analyses for this end point

Secondary: DR for Combination C

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End point title

DR for Combination C ^[70]

End point description

End point type

Secondary

End point timeframe

From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum up to 1.8 years)

Notes
[70] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-C Ph-1b PD 0360324 50mg +Avelumab	Com-C Ph-1b PD 0360324 100mg +Avelumab	Com-C Ph-1b PD 0360324 150mg +Avelumab
Number of subjects analysed	1	2	1
Units: Months
median (full range (min-max))	7.1 (7.1 to 7.1)	7.1 (5.6 to 8.6)	13.1 (13.1 to 13.1)

No statistical analyses for this end point

Secondary: DR for Combination B

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End point title

DR for Combination B ^[71]

End point description

End point type

Secondary

End point timeframe

From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum up to 3.5 years)

Notes
[71] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-B Ph-1b PF-04518600 0.3mg/kg +Avelumab	Com-B Ph-1b PF-04518600 1.0 mg/kg +Avelumab	Com-B Ph-1b PF-04518600 3.0 mg/kg +Avelumab	Com-B Ph-2 NSCLC PF-04518600 0.3 mg/kg +Avelumab	Com-B Ph-2 SCCHN PF-04518600 0.3 mg/kg +Avelumab
Number of subjects analysed	0 ^[72]	0 ^[73]	0 ^[74]	2	2
Units: Months
median (full range (min-max))	( to )	( to )	( to )	5.6 (3.7 to 7.4)	23.5 (20.9 to 26.0)

Notes
[72] - No subjects were analyzed for this reporting group.
[73] - No subjects were analyzed for this reporting group.
[74] - No subjects were analyzed for this reporting group.

No statistical analyses for this end point

Secondary: DR for Combination F

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End point title

DR for Combination F ^[75]

End point description

End point type

Secondary

End point timeframe

From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum up to 3 years)

Notes
[75] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-F Ph-1b SCCHN CMP-001 10mg +Avelumab	Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg	Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg
Number of subjects analysed	0 ^[76]	1	0 ^[77]
Units: Months
median (full range (min-max))	( to )	18.7 (18.7 to 18.7)	( to )

Notes
[76] - No subjects were analyzed for this reporting group.
[77] - No subjects were analyzed for this reporting group.

No statistical analyses for this end point

Secondary: Progression-free Survival (PFS) for Combination A

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End point title

Progression-free Survival (PFS) for Combination A ^[78]

End point description

PFS as assessed by investigator per RECIST v1.1, was defined as time (in months) from date of first dose of study drug to date of first documentation of PD or death due to any cause or data censoring date, whichever occurred first. PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on study treatment (this included baseline sum if that was smallest on study treatment). The sum must also demonstrate absolute increase of >=5 mm, or appearance of >=1 new lesions. PFS was analyzed by Kaplan-Meier method. PFS data was censored on the date the last adequate tumor assessment for subjects without an event (PD or death), for subjects who started new anti-cancer treatment prior to PFS event, for subjects with a PFS event after >=2 missing tumor assessments. Full analysis set included all subjects who received at least one dose of study drug. 99999 indicates Upper limit of 95% CI was not estimable as there were less number of subjects with an event.

End point type

Secondary

End point timeframe

From first dose of study drug until first documentation of PD or death due to any cause or data censoring date, whichever occurred first (maximum up to 6.5 years)

Notes
[78] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab	Com-A Ph-2 Melanoma Utomilumab 100mg+Avelumab	Com-A Ph-2 SCCHN Utomilumab 100mg+Avelumab	Com-A Ph-2 TNBC Utomilumab 100mg+Avelumab	Com-A Ph-2 SCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1st line(1L) NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab	Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab
Number of subjects analysed	29	28	29	28	35	21	10	21	11	11
Units: Months
median (confidence interval 95%)	2.2 (1.8 to 5.3)	1.8 (1.7 to 2.3)	1.9 (1.7 to 3.7)	1.9 (1.8 to 3.9)	1.9 (1.8 to 3.7)	1.8 (1.4 to 5.5)	1.6 (0.3 to 5.4)	1.8 (1.7 to 3.6)	11.9 (4.2 to 99999)	5.5 (0.7 to 43.5)

No statistical analyses for this end point

Secondary: PFS for Combination B

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End point title

PFS for Combination B ^[79]

End point description

End point type

Secondary

End point timeframe

From first dose of study drug until first documentation of PD or death due to any cause or data censoring date, whichever occurred first (maximum up to 3.5 years)

Notes
[79] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-B Ph-1b PF-04518600 0.3mg/kg +Avelumab	Com-B Ph-1b PF-04518600 1.0 mg/kg +Avelumab	Com-B Ph-1b PF-04518600 3.0 mg/kg +Avelumab	Com-B Ph-2 NSCLC PF-04518600 0.3 mg/kg +Avelumab	Com-B Ph-2 SCCHN PF-04518600 0.3 mg/kg +Avelumab
Number of subjects analysed	12	12	8	14	25
Units: Months
median (confidence interval 95%)	1.7 (0.7 to 1.8)	1.8 (1.0 to 2.7)	1.7 (0.9 to 99999)	3.7 (1.8 to 5.6)	1.8 (1.7 to 2.1)

No statistical analyses for this end point

Secondary: PFS for Combination C

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End point title

PFS for Combination C ^[80]

End point description

End point type

Secondary

End point timeframe

From first dose of study drug until first documentation of PD or death due to any cause or data censoring date, whichever occurred first (maximum up to 1.8 years)

Notes
[80] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-C Ph-1b PD 0360324 50mg +Avelumab	Com-C Ph-1b PD 0360324 100mg +Avelumab	Com-C Ph-1b PD 0360324 150mg +Avelumab
Number of subjects analysed	10	8	6
Units: Months
median (confidence interval 95%)	1.9 (0.5 to 99999)	9.0 (1.1 to 99999)	12.2 (1.7 to 99999)

No statistical analyses for this end point

Secondary: PFS for Combination D

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End point title

PFS for Combination D ^[81]

End point description

End point type

Secondary

End point timeframe

From first dose of study drug until first documentation of PD or death due to any cause or data censoring date, whichever occurred first (maximum up to 4.5 years)

Notes
[81] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab
Number of subjects analysed	12	12	12	12	12	11
Units: Months
median (confidence interval 95%)	1.8 (1.1 to 9.2)	1.8 (1.3 to 99999)	3.7 (1.0 to 23.8)	1.8 (1.2 to 99999)	1.8 (1.4 to 3.1)	1.8 (0.6 to 1.9)

No statistical analyses for this end point

Secondary: Overall Survival (OS) for Combination A

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End point title

Overall Survival (OS) for Combination A ^[82]

End point description

OS was defined as the time (in months) from the date of first dose of study drug to the date of death due to any cause or data censoring date, whichever occurred first. Subjects last known to be alive were censored at the date of last contact. OS was analyzed by Kaplan-Meier method. Full analysis set included all subjects who received at least one dose of study drug. 99999 indicates Upper limit of 95% CI was not estimable as there were less number of subjects with an event.

End point type

Secondary

End point timeframe

From first dose of study drug to date of death from any cause or data censoring date, whichever occurred first (maximum up to 6.5 years)

Notes
[82] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab	Com-A Ph-2 Melanoma Utomilumab 100mg+Avelumab	Com-A Ph-2 SCCHN Utomilumab 100mg+Avelumab	Com-A Ph-2 TNBC Utomilumab 100mg+Avelumab	Com-A Ph-2 SCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1st line(1L) NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab	Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab
Number of subjects analysed	29	28	29	28	35	21	10	21	11	11
Units: Months
median (confidence interval 95%)	14.5 (6.2 to 36.1)	12.7 (3.0 to 16.1)	14.7 (6.8 to 22.0)	8.1 (6.4 to 15.2)	10.7 (7.7 to 16.9)	10.9 (4.7 to 99999)	11.3 (0.4 to 99999)	12.8 (6.9 to 18.9)	29.3 (5.8 to 99999)	22.1 (3.4 to 99999)

No statistical analyses for this end point

Secondary: PFS for Combination F

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End point title

PFS for Combination F ^[83]

End point description

End point type

Secondary

End point timeframe

From first dose of study drug until first documentation of PD or death due to any cause or data censoring date, whichever occurred first (maximum up to 3 years)

Notes
[83] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-F Ph-1b SCCHN CMP-001 10mg +Avelumab	Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg	Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg
Number of subjects analysed	6	7	7
Units: Months
median (confidence interval 95%)	2.3 (1.7 to 99999)	1.9 (1.7 to 99999)	1.8 (1.3 to 3.6)

No statistical analyses for this end point

Secondary: OS for Combination B

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End point title

OS for Combination B ^[84]

End point description

End point type

Secondary

End point timeframe

From first dose of study drug to date of death from any cause or data censoring date, whichever occurred first (maximum up to 3.5 years)

Notes
[84] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-B Ph-1b PF-04518600 0.3mg/kg +Avelumab	Com-B Ph-1b PF-04518600 1.0 mg/kg +Avelumab	Com-B Ph-1b PF-04518600 3.0 mg/kg +Avelumab	Com-B Ph-2 NSCLC PF-04518600 0.3 mg/kg +Avelumab	Com-B Ph-2 SCCHN PF-04518600 0.3 mg/kg +Avelumab
Number of subjects analysed	12	12	8	14	25
Units: Months
median (confidence interval 95%)	8.5 (1.6 to 99999)	13.5 (4.0 to 99999)	7.1 (2.4 to 20.8)	15.9 (6.3 to 99999)	10.7 (6.7 to 14.5)

No statistical analyses for this end point

Secondary: OS for Combination C

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End point title

OS for Combination C ^[85]

End point description

End point type

Secondary

End point timeframe

From first dose of study drug to date of death from any cause or data censoring date, whichever occurred first (maximum up to 1.8 years)

Notes
[85] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-C Ph-1b PD 0360324 50mg +Avelumab	Com-C Ph-1b PD 0360324 100mg +Avelumab	Com-C Ph-1b PD 0360324 150mg +Avelumab
Number of subjects analysed	10	8	6
Units: Months
median (confidence interval 95%)	16.3 (0.5 to 99999)	30.9 (1.1 to 99999)	17.3 (6.3 to 99999)

No statistical analyses for this end point

Secondary: OS for Combination F

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End point title

OS for Combination F ^[86]

End point description

End point type

Secondary

End point timeframe

From first dose of study drug to date of death from any cause or data censoring date, whichever occurred first (maximum up to 3 years)

Notes
[86] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-F Ph-1b SCCHN CMP-001 10mg +Avelumab	Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg	Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg
Number of subjects analysed	6	7	7
Units: Months
median (confidence interval 95%)	10.0 (2.2 to 99999)	11.7 (2.0 to 99999)	5.9 (3.0 to 7.9)

No statistical analyses for this end point

Secondary: OS for Combination D

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End point title

OS for Combination D ^[87]

End point description

End point type

Secondary

End point timeframe

From first dose of study drug to date of death from any cause or data censoring date, whichever occurred first (maximum up to 4.5 years)

Notes
[87] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab
Number of subjects analysed	12	12	12	12	12	11
Units: Months
median (confidence interval 95%)	9.4 (3.7 to 23.5)	7.4 (1.7 to 99999)	16.2 (5.1 to 99999)	6.1 (1.2 to 22.5)	8.5 (3.4 to 25.2)	6.6 (1.8 to 99999)

No statistical analyses for this end point

Secondary: Phase 1b: Percentage of Subjects With Objective Response (OR) for Combination A

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End point title

Phase 1b: Percentage of Subjects With Objective Response (OR) for Combination A ^[88]

End point description

OR as assessed by investigator per RECIST v.1.1, was defined as participants with confirmed best overall response of complete response (CR) or partial response (PR), were recorded from first dose of study drug until disease progression or death due to any cause. CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as >=30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Full analysis set included all subjects who received at least one dose of study drug.

End point type

Secondary

End point timeframe

Screening, Day 1 of each cycle starting Cycle 3, up to end of treatment/withdrawal (approximately 34 months)

Notes
[88] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab
Number of subjects analysed	29	28	29
Units: Percentage of subjects
number (confidence interval 95%)	3.4 (0.1 to 17.8)	0 (0.0 to 12.3)	10.3 (2.2 to 27.4)

No statistical analyses for this end point

Secondary: Phase 1b: Percentage of Subjects With Objective Response (OR) for Combination C

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End point title

Phase 1b: Percentage of Subjects With Objective Response (OR) for Combination C ^[89]

End point description

End point type

Secondary

End point timeframe

From first dose of study drug until disease progression or death due to any cause (maximum up to 13 months)

Notes
[89] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-C Ph-1b PD 0360324 50mg +Avelumab	Com-C Ph-1b PD 0360324 100mg +Avelumab	Com-C Ph-1b PD 0360324 150mg +Avelumab
Number of subjects analysed	10	8	6
Units: Percentage of subjects
number (confidence interval 95%)	10.0 (0.3 to 44.5)	25.0 (3.2 to 65.1)	16.7 (0.4 to 64.1)

No statistical analyses for this end point

Secondary: Phase 1b: Percentage of Subjects With Objective Response (OR) for Combination D

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End point title

Phase 1b: Percentage of Subjects With Objective Response (OR) for Combination D ^[90]

End point description

End point type

Secondary

End point timeframe

From first dose of study drug until disease progression or death due to any cause (maximum up to 49 months)

Notes
[90] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab
Number of subjects analysed	12	12	12	12	12	11
Units: Percentage of subjects
number (confidence interval 95%)	8.3 (0.2 to 38.5)	33.3 (9.9 to 65.1)	25.0 (5.5 to 57.2)	8.3 (0.2 to 38.5)	8.3 (0.2 to 38.5)	18.2 (2.3 to 51.8)

No statistical analyses for this end point

Secondary: Phase 1b: Percentage of Subjects With Objective Response (OR) for Combination B

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End point title

Phase 1b: Percentage of Subjects With Objective Response (OR) for Combination B ^[91]

End point description

End point type

Secondary

End point timeframe

From first dose of study drug until disease progression or death due to any cause (maximum up to 26 months)

Notes
[91] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-B Ph-1b PF-04518600 0.3mg/kg +Avelumab	Com-B Ph-1b PF-04518600 1.0 mg/kg +Avelumab	Com-B Ph-1b PF-04518600 3.0 mg/kg +Avelumab
Number of subjects analysed	12	12	8
Units: Percentage of subjects
number (confidence interval 95%)	0 (0.0 to 26.5)	0 (0.0 to 26.5)	0 (0.0 to 36.9)

No statistical analyses for this end point

Secondary: Phase 1b: Percentage of Subjects With Objective Response (OR) for Combination F

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End point title

Phase 1b: Percentage of Subjects With Objective Response (OR) for Combination F ^[92]

End point description

End point type

Secondary

End point timeframe

From first dose of study drug until disease progression or death due to any cause (maximum up to 18 months)

Notes
[92] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-F Ph-1b SCCHN CMP-001 10mg +Avelumab	Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg	Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg
Number of subjects analysed	6	7	7
Units: Percentage of subjects
number (confidence interval 95%)	0 (0.0 to 45.9)	14.3 (0.4 to 57.9)	0 (0.0 to 41.0)

No statistical analyses for this end point

Secondary: Number of Subjects With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination A

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End point title

Number of Subjects With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination A ^[93]

End point description

PD-L1 protein expression is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen is considered to have PD-L1 expression if TPS >=1% and high PD-L1 expression if TPS >= 50%. Tumor infiltrating CD8+ lymphocytes is defined as the number of CD8+ cells per unit area and the percent of counted cells. Positive is defined as >=1% and negative is defined as <1%. The analysis population was a subset of the safety analysis set (all subjects who received at least one dose of study drug) and included subjects who had at least one biomarker parameter of PD-L1 and CD8+ lymphocytes from the corresponding assay sample with at least one baseline biomarker measurement.

End point type

Secondary

End point timeframe

Baseline (Day 1)

Notes
[93] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab	Com-A Ph-2 Melanoma Utomilumab 100mg+Avelumab	Com-A Ph-2 SCCHN Utomilumab 100mg+Avelumab	Com-A Ph-2 TNBC Utomilumab 100mg+Avelumab	Com-A Ph-2 SCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1st line(1L) NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab	Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab
Number of subjects analysed	24	24	22	22	24	18	8	18	9	8
Units: Subjects
PD-L1, n= 24,24,22,22,24,18,8,18,9,8	24	24	22	22	24	18	8	18	9	8
CD8+, n= 24,24,22,21,24,18,8,18,9,8	24	24	22	21	24	18	8	18	9	8

No statistical analyses for this end point

Secondary: Number of Subjects With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination B

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End point title

Number of Subjects With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination B ^[94]

End point description

End point type

Secondary

End point timeframe

Baseline (Day 1)

Notes
[94] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-B Ph-1b PF-04518600 0.3mg/kg +Avelumab	Com-B Ph-1b PF-04518600 1.0 mg/kg +Avelumab	Com-B Ph-1b PF-04518600 3.0 mg/kg +Avelumab	Com-B Ph-2 NSCLC PF-04518600 0.3 mg/kg +Avelumab	Com-B Ph-2 SCCHN PF-04518600 0.3 mg/kg +Avelumab
Number of subjects analysed	4	8	4	10	19
Units: Subjects
PD-L1, n=4,8,4,10,19	4	8	4	10	19
CD8+, n=3,8,4,10,18	3	8	4	10	18

No statistical analyses for this end point

Secondary: Number of Subjects With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination C

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End point title

Number of Subjects With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination C ^[95]

End point description

End point type

Secondary

End point timeframe

Baseline (Day 1)

Notes
[95] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-C Ph-1b PD 0360324 50mg +Avelumab	Com-C Ph-1b PD 0360324 100mg +Avelumab	Com-C Ph-1b PD 0360324 150mg +Avelumab
Number of subjects analysed	6	3	4
Units: Subjects
PD-L1	6	3	4
CD8+	6	3	4

No statistical analyses for this end point

Secondary: Number of Subjects With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination D

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End point title

Number of Subjects With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination D ^[96]

End point description

End point type

Secondary

End point timeframe

Baseline (Day 1)

Notes
[96] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab
Number of subjects analysed	9	8	11	10	10	10
Units: Subjects
PD-L1, n=9,8,11,10,10,10	9	8	11	10	10	10
CD8+, n=8,8,11,9,10,10	8	8	11	9	10	10

No statistical analyses for this end point

Secondary: Number of Subjects With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination F

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End point title

Number of Subjects With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination F ^[97]

End point description

End point type

Secondary

End point timeframe

Baseline (Day 1)

Notes
[97] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is reporting statistics for the arms specified

End point values	Com-F Ph-1b SCCHN CMP-001 10mg +Avelumab	Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg	Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg
Number of subjects analysed	4	7	5
Units: Subjects
PD-L1	4	7	5
CD8+	4	7	5

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Baseline up to 30 days post last dose (up to 6.5 years [Combination-A], 3.5 years [Combination-B], 1.8 years [Combination-C], 4.3 years [Combination-D] and 3 years [Combination-F]). All-Cause Mortality assessed up to 7.3 years

Adverse event reporting additional description

The same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in another, or 1 participant may experience both an AE and SAE event during the study. AE and SAE’s report all participants who received at least 1 dose. All-Cause Mortality reports all randomized participants in the study.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

26.0

Reporting group title

Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab

Reporting group description

During phase 1b subjects with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab

Reporting group description

During phase 1b subjects with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-B Ph-1b PF-04518600 0.3mg/kg +Avelumab

Reporting group description

During Phase 1b subjects received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.

Reporting group title

Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab

Reporting group description

During Phase 2 subjects with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.

Reporting group title

Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab

Reporting group description

During Phase 2 subjects with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.

Reporting group title

Com-A Ph-2 SCLC Utomilumab 100mg+Avelumab

Reporting group description

During Phase 2 subjects with Squamous cell lung cancer (SCLC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-A Ph-2 1st line(1L) NSCLC Utomilumab 100mg+Avelumab

Reporting group description

During Phase 2 subjects with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-A Ph-2 Melanoma Utomilumab 100mg+Avelumab

Reporting group description

During Phase 2 subjects with melanoma received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab

Reporting group description

Reporting group title

Com-B Ph-1b PF-04518600 3.0 mg/kg +Avelumab

Reporting group description

During Phase 1b subjects received PF-04518600 3.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.

Reporting group title

Com-B Ph-1b PF-04518600 1.0 mg/kg +Avelumab

Reporting group description

During Phase 1b subjects received PF-04518600 1.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.

Reporting group title

Com-A Ph-2 TNBC Utomilumab 100mg+Avelumab

Reporting group description

During Phase 2 subjects with Triple Negative Breast Cancer (TNBC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-A Ph-2 SCCHN Utomilumab 100mg+Avelumab

Reporting group description

Reporting group title

Com-B Ph-2 NSCLC PF-04518600 0.3 mg/kg +Avelumab

Reporting group description

During Phase 2 subjects with NSCLC received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.

Reporting group title

Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab

Reporting group description

Reporting group title

Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab

Reporting group description

Reporting group title

Com-C Ph-1b PD 0360324 150mg +Avelumab

Reporting group description

During Phase 1b subjects received PD 0360324 150 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-C Ph-1b PD 0360324 100mg +Avelumab

Reporting group description

During Phase 1b subjects received PD 0360324 100 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Reporting group title

Com-C Ph-1b PD 0360324 50mg +Avelumab

Reporting group description

During Phase 1b subjects received PD 0360324 50 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.

Reporting group title

Com-B Ph-2 SCCHN PF-04518600 0.3 mg/kg +Avelumab

Reporting group description

During Phase 2 subjects with SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.

Reporting group title

Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab

Reporting group description

Reporting group title

Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab

Reporting group description

Reporting group title

Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg

Reporting group description

Reporting group title

Com-F Ph-1b SCCHN CMP-001 10mg +Avelumab

Reporting group description

Reporting group title

Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab

Reporting group description

Reporting group title

Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab

Reporting group description

Reporting group title

Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg

Reporting group description

During Phase 1b subjects with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus PF-04518600 at 0.3 mg/kg administered IV Q2W. Phase 2 was not planned.

Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab

Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab

Com-B Ph-1b PF-04518600 0.3mg/kg +Avelumab

Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab

Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab

Com-A Ph-2 SCLC Utomilumab 100mg+Avelumab

Com-A Ph-2 1st line(1L) NSCLC Utomilumab 100mg+Avelumab

Com-A Ph-2 Melanoma Utomilumab 100mg+Avelumab

Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab

Com-B Ph-1b PF-04518600 3.0 mg/kg +Avelumab

Com-B Ph-1b PF-04518600 1.0 mg/kg +Avelumab

Com-A Ph-2 TNBC Utomilumab 100mg+Avelumab

Com-A Ph-2 SCCHN Utomilumab 100mg+Avelumab

Com-B Ph-2 NSCLC PF-04518600 0.3 mg/kg +Avelumab

Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab

Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab

Com-C Ph-1b PD 0360324 150mg +Avelumab

Com-C Ph-1b PD 0360324 100mg +Avelumab

Com-C Ph-1b PD 0360324 50mg +Avelumab

Com-B Ph-2 SCCHN PF-04518600 0.3 mg/kg +Avelumab

Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab

Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab

Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg

Com-F Ph-1b SCCHN CMP-001 10mg +Avelumab

Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab

Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab

Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg

Total subjects affected by serious adverse events

subjects affected / exposed

12 / 28 (42.86%)

13 / 29 (44.83%)

3 / 12 (25.00%)

1 / 11 (9.09%)

4 / 11 (36.36%)

4 / 10 (40.00%)

8 / 21 (38.10%)

9 / 28 (32.14%)

11 / 29 (37.93%)

1 / 8 (12.50%)

4 / 12 (33.33%)

4 / 21 (19.05%)

16 / 35 (45.71%)

3 / 14 (21.43%)

5 / 11 (45.45%)

4 / 12 (33.33%)

4 / 6 (66.67%)

3 / 8 (37.50%)

4 / 10 (40.00%)

10 / 25 (40.00%)

3 / 12 (25.00%)

2 / 12 (16.67%)

4 / 7 (57.14%)

2 / 6 (33.33%)

5 / 12 (41.67%)

4 / 12 (33.33%)

4 / 7 (57.14%)

number of deaths (all causes)

number of deaths resulting from adverse events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder transitional cell carcinoma

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

1 / 14 (7.14%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Squamous cell carcinoma

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

1 / 12 (8.33%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Squamous cell carcinoma of head and neck

alternative assessment type: Systematic

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

1 / 11 (9.09%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 2

0 / 0

Lentigo maligna

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

1 / 28 (3.57%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Breast cancer

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

1 / 21 (4.76%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lung cancer metastatic

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

1 / 10 (10.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Malignant neoplasm progression

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

1 / 10 (10.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

1 / 8 (12.50%)

1 / 10 (10.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Neoplasm progression

subjects affected / exposed

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Tumour haemorrhage

alternative assessment type: Systematic

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Oncologic complication

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular disorders

Orthostatic hypotension

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

1 / 25 (4.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Embolism

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

1 / 10 (10.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haematoma

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

1 / 7 (14.29%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Superior vena cava syndrome

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

1 / 10 (10.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Deep vein thrombosis

alternative assessment type: Systematic

subjects affected / exposed

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Flushing

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypertension

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

General disorders and administration site conditions

Mucosal inflammation

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

1 / 10 (10.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Death

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Multiple organ dysfunction syndrome

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

1 / 11 (9.09%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

Pain

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

1 / 7 (14.29%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Asthenia

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

1 / 10 (10.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

1 / 8 (12.50%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

1 / 14 (7.14%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Disease progression

subjects affected / exposed

4 / 28 (14.29%)

2 / 29 (6.90%)

1 / 12 (8.33%)

1 / 11 (9.09%)

0 / 11 (0.00%)

0 / 10 (0.00%)

1 / 21 (4.76%)

1 / 28 (3.57%)

2 / 29 (6.90%)

0 / 8 (0.00%)

1 / 12 (8.33%)

1 / 21 (4.76%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 4

0 / 3

0 / 1

0 / 0

0 / 1

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Fatigue

subjects affected / exposed

1 / 28 (3.57%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Inflammation

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Non-cardiac chest pain

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Immune system disorders

Cytokine release syndrome

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

2 / 7 (28.57%)

0 / 6 (0.00%)

0 / 12 (0.00%)

2 / 7 (28.57%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

2 / 2

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

Pharyngeal haemorrhage

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

1 / 6 (16.67%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Laryngeal oedema

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

1 / 7 (14.29%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonitis aspiration

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

1 / 7 (14.29%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Asthma

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

1 / 28 (3.57%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Bronchial obstruction

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

1 / 21 (4.76%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Chronic obstructive pulmonary disease

subjects affected / exposed

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 12 (0.00%)

0 / 11 (0.00%)

1 / 10 (10.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

1 / 8 (12.50%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Dyspnoea

subjects affected / exposed

1 / 28 (3.57%)

0 / 29 (0.00%)

2 / 12 (16.67%)

0 / 11 (0.00%)

2 / 10 (20.00%)

1 / 21 (4.76%)

0 / 28 (0.00%)

2 / 29 (6.90%)

0 / 8 (0.00%)

0 / 12 (0.00%)

1 / 21 (4.76%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

1 / 8 (12.50%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 2

0 / 0

0 / 3

1 / 1

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Pleural effusion

subjects affected / exposed

1 / 28 (3.57%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Hypoxia

subjects affected / exposed

1 / 28 (3.57%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

1 / 10 (10.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haemoptysis

subjects affected / exposed

1 / 28 (3.57%)

1 / 29 (3.45%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonitis

subjects affected / exposed

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

1 / 14 (7.14%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pulmonary embolism

subjects affected / exposed

1 / 28 (3.57%)

1 / 29 (3.45%)

0 / 12 (0.00%)

0 / 11 (0.00%)

1 / 11 (9.09%)

0 / 10 (0.00%)

0 / 21 (0.00%)

1 / 28 (3.57%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

1 / 10 (10.00%)

1 / 25 (4.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

1 / 7 (14.29%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Pulmonary haemorrhage

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Psychiatric disorders

Mental status changes

alternative assessment type: Systematic

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

1 / 25 (4.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Anxiety

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

1 / 12 (8.33%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Investigations

Alanine aminotransferase increased

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

1 / 6 (16.67%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Aspartate aminotransferase increased

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

1 / 6 (16.67%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Troponin increased

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

1 / 11 (9.09%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lymphocyte count decreased

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

2 / 7 (28.57%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Oxygen saturation decreased

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Lumbar vertebral fracture

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

1 / 12 (8.33%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Wound haemorrhage

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

1 / 25 (4.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Wound

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

1 / 6 (16.67%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular pseudoaneurysm

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

1 / 7 (14.29%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Fall

subjects affected / exposed

1 / 28 (3.57%)

1 / 29 (3.45%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Spinal fracture

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

1 / 28 (3.57%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Infusion related reaction

subjects affected / exposed

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 12 (0.00%)

0 / 11 (0.00%)

2 / 11 (18.18%)

0 / 10 (0.00%)

0 / 21 (0.00%)

1 / 28 (3.57%)

1 / 29 (3.45%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

1 / 11 (9.09%)

0 / 12 (0.00%)

1 / 6 (16.67%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

2 / 2

0 / 0

2 / 2

1 / 1

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Wound dehiscence

subjects affected / exposed

1 / 28 (3.57%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

1 / 14 (7.14%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Pericarditis

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

1 / 12 (8.33%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Myocarditis

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

1 / 11 (9.09%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac arrest

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

1 / 10 (10.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

Atrial fibrillation

subjects affected / exposed

1 / 28 (3.57%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Angina pectoris

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

1 / 11 (9.09%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac tamponade

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

1 / 11 (9.09%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pericardial effusion

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

1 / 11 (9.09%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nervous system disorders

Embolic stroke

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

1 / 12 (8.33%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Lacunar infarction

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

1 / 8 (12.50%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Spinal cord compression

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

1 / 12 (8.33%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Neuralgia

alternative assessment type: Systematic

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

1 / 12 (8.33%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Subarachnoid haemorrhage

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cerebrovascular accident

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Partial seizures

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ischaemic stroke

subjects affected / exposed

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Syncope

subjects affected / exposed

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

1 / 25 (4.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

1 / 6 (16.67%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Blood and lymphatic system disorders

Immune thrombocytopenia

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

1 / 12 (8.33%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ear and labyrinth disorders

Vertigo

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

1 / 21 (4.76%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Eye disorders

Blindness

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

1 / 25 (4.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Intestinal perforation

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

1 / 25 (4.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

1 / 1

0 / 0

Large intestine perforation

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

1 / 14 (7.14%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pancreatitis

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

1 / 25 (4.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Mouth haemorrhage

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

1 / 12 (8.33%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Oesophageal fistula

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

1 / 10 (10.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Small intestinal obstruction

alternative assessment type: Systematic

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

1 / 10 (10.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haematemesis

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Dysphagia

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Oral cavity fistula

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Abdominal pain

alternative assessment type: Systematic

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

1 / 21 (4.76%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Colitis

subjects affected / exposed

1 / 28 (3.57%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

1 / 21 (4.76%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Constipation

subjects affected / exposed

1 / 28 (3.57%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Diarrhoea

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

1 / 28 (3.57%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal haemorrhage

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

1 / 28 (3.57%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nausea

subjects affected / exposed

1 / 28 (3.57%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

1 / 21 (4.76%)

0 / 28 (0.00%)

0 / 29 (0.00%)

1 / 8 (12.50%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Intestinal obstruction

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Small intestinal perforation

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Oesophageal obstruction

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vomiting

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

1 / 21 (4.76%)

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

Bile duct stone

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatic haemorrhage

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Immune-mediated hepatitis

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

1 / 21 (4.76%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

Chronic kidney disease

alternative assessment type: Systematic

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

1 / 11 (9.09%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Acute kidney injury

subjects affected / exposed

1 / 28 (3.57%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

Compartment syndrome

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

1 / 7 (14.29%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Arthralgia

subjects affected / exposed

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Back pain

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

1 / 21 (4.76%)

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

1 / 11 (9.09%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Muscular weakness

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

1 / 21 (4.76%)

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pain in extremity

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

2 / 35 (5.71%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Neck pain

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

Pneumonia aspiration

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

2 / 7 (28.57%)

1 / 6 (16.67%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Herpes zoster

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

1 / 12 (8.33%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Influenza

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

1 / 7 (14.29%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Bronchitis

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

1 / 21 (4.76%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Fungaemia

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lower respiratory tract infection

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

1 / 28 (3.57%)

1 / 29 (3.45%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Gastroenteritis

subjects affected / exposed

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lung abscess

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

1 / 21 (4.76%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lower respiratory tract infection viral

subjects affected / exposed

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Osteomyelitis

subjects affected / exposed

1 / 28 (3.57%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

1 / 25 (4.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia

subjects affected / exposed

1 / 28 (3.57%)

2 / 29 (6.90%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 8 (0.00%)

0 / 12 (0.00%)

1 / 21 (4.76%)

2 / 35 (5.71%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

1 / 10 (10.00%)

1 / 25 (4.00%)

0 / 12 (0.00%)

1 / 7 (14.29%)

0 / 6 (0.00%)

0 / 12 (0.00%)

1 / 7 (14.29%)

occurrences causally related to treatment / all

0 / 1

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

0 / 2

0 / 0

0 / 1

0 / 0

1 / 2

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Phlebitis infective

subjects affected / exposed

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Sepsis

subjects affected / exposed

1 / 28 (3.57%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

1 / 8 (12.50%)

0 / 10 (0.00%)

1 / 25 (4.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urinary tract infection

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

1 / 28 (3.57%)

0 / 29 (0.00%)

0 / 8 (0.00%)

1 / 12 (8.33%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Wound infection

subjects affected / exposed

1 / 28 (3.57%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

Failure to thrive

alternative assessment type: Systematic

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

1 / 14 (7.14%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Hypoglycaemia

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

1 / 6 (16.67%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Diabetes mellitus

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Diabetic ketoacidosis

subjects affected / exposed

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypercalcaemia

subjects affected / exposed

1 / 28 (3.57%)

0 / 29 (0.00%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

1 / 35 (2.86%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Hyponatraemia

subjects affected / exposed

0 / 28 (0.00%)

1 / 29 (3.45%)

0 / 12 (0.00%)

0 / 11 (0.00%)

0 / 10 (0.00%)

0 / 21 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 8 (0.00%)

0 / 12 (0.00%)

0 / 21 (0.00%)

0 / 35 (0.00%)

0 / 14 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 6 (0.00%)

0 / 8 (0.00%)

0 / 10 (0.00%)

0 / 25 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 12 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Com-A Ph-1b NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-1b NSCLC Utomilumab 20mg+Avelumab	Com-B Ph-1b PF-04518600 0.3mg/kg +Avelumab	Com-A Ph-2 1L NSCLC Avelumab then Utomilumab + Avelumab	Com-A Ph-2 1L NSCLC Utomilumab then Utomilumab + Avelumab	Com-A Ph-2 SCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 1st line(1L) NSCLC Utomilumab 100mg+Avelumab	Com-A Ph-2 Melanoma Utomilumab 100mg+Avelumab	Com-A Phase (Ph)-1b NSCLC Utomilumab 500mg+Avelumab	Com-B Ph-1b PF-04518600 3.0 mg/kg +Avelumab	Com-B Ph-1b PF-04518600 1.0 mg/kg +Avelumab	Com-A Ph-2 TNBC Utomilumab 100mg+Avelumab	Com-A Ph-2 SCCHN Utomilumab 100mg+Avelumab	Com-B Ph-2 NSCLC PF-04518600 0.3 mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 1.0mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 1.0mg/kg +Avelumab	Com-C Ph-1b PD 0360324 150mg +Avelumab	Com-C Ph-1b PD 0360324 100mg +Avelumab	Com-C Ph-1b PD 0360324 50mg +Avelumab	Com-B Ph-2 SCCHN PF-04518600 0.3 mg/kg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.1mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.1mg/kg +Avelumab	Com-F Ph-1b SCCHN CMP-001 10mg then Avelumab+Utomilumab 100mg	Com-F Ph-1b SCCHN CMP-001 10mg +Avelumab	Com-D Ph-1b Utomilumab 50mg + PF-04518600 0.3mg/kg +Avelumab	Com-D Ph-1b Utomilumab 20mg + PF-04518600 0.3mg/kg +Avelumab	Co-F Ph1b SCCHN CMP-001 10mg then Avelumab+PF-04518600 0.3mgkg
Total subjects affected by non serious adverse events
subjects affected / exposed	28 / 28 (100.00%)	28 / 29 (96.55%)	12 / 12 (100.00%)	10 / 11 (90.91%)	11 / 11 (100.00%)	10 / 10 (100.00%)	21 / 21 (100.00%)	28 / 28 (100.00%)	29 / 29 (100.00%)	8 / 8 (100.00%)	12 / 12 (100.00%)	20 / 21 (95.24%)	33 / 35 (94.29%)	14 / 14 (100.00%)	11 / 11 (100.00%)	12 / 12 (100.00%)	6 / 6 (100.00%)	8 / 8 (100.00%)	9 / 10 (90.00%)	25 / 25 (100.00%)	11 / 12 (91.67%)	12 / 12 (100.00%)	7 / 7 (100.00%)	5 / 6 (83.33%)	11 / 12 (91.67%)	12 / 12 (100.00%)	7 / 7 (100.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Metastases to central nervous system
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Skin papilloma
subjects affected / exposed	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	1	0	0	0	1	0	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Tumour pain
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	4 / 35 (11.43%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	1	0	0	1	0	0	2	0	4	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Tumour haemorrhage
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	2 / 25 (8.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	1	0	0	0	0	0	0
Lentigo maligna
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Squamous cell carcinoma
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Basal cell carcinoma
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Vascular disorders
Orthostatic hypotension
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0
Deep vein thrombosis
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0
Peripheral venous disease
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Jugular vein thrombosis
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Haemorrhage
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Lymphoedema
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Superficial vein thrombosis
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Vena cava thrombosis
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Scalp haematoma
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Surgical and medical procedures
Sinus operation
subjects affected / exposed	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	1	0	0	1	0	0	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Flushing
subjects affected / exposed	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	2 / 21 (9.52%)	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	1	2	0	0	0	0	2	2	1	0	2	1	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Hot flush
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	1 / 11 (9.09%)	0 / 10 (0.00%)	1 / 21 (4.76%)	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	1	1	0	1	0	1	0	2	1	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Hypertension
subjects affected / exposed	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	3 / 21 (14.29%)	2 / 28 (7.14%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	2 / 35 (5.71%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	1	0	0	1	0	3	2	1	0	2	0	2	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Hypotension
subjects affected / exposed	1 / 28 (3.57%)	2 / 29 (6.90%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	2 / 10 (20.00%)	0 / 21 (0.00%)	1 / 28 (3.57%)	2 / 29 (6.90%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	2	3	0	0	0	2	0	1	4	0	2	0	1	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Superior vena cava syndrome
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
General disorders and administration site conditions
Face oedema
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	1	0	0	2	0
Early satiety
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Peripheral swelling
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)	1 / 6 (16.67%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	1	0	1	0
Mucosal inflammation
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	1 / 8 (12.50%)	1 / 10 (10.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	1	2	0	1	1	0	0	0	0	0
Ill-defined disorder
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Swelling
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	2 / 10 (20.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0
Swelling face
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	3 / 12 (25.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	1	0	4	0
Temperature intolerance
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Application site rash
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Catheter site related reaction
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Facial pain
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Necrosis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Axillary pain
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Drug withdrawal syndrome
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Induration
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0
Hernia pain
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Medical device site burn
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Impaired healing
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Injection site nodule
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	2	0	0	0
Injection site reaction
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	3 / 7 (42.86%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	3 / 7 (42.86%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	0	0	0	3
Asthenia
subjects affected / exposed	3 / 28 (10.71%)	5 / 29 (17.24%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	2 / 21 (9.52%)	2 / 28 (7.14%)	1 / 29 (3.45%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 21 (4.76%)	5 / 35 (14.29%)	2 / 14 (14.29%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	1 / 25 (4.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	4	7	0	0	0	1	2	2	1	0	0	1	6	2	0	1	0	0	2	1	2	0	1	0	1	2	2
Catheter site pain
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	1	0	0	0
Chest discomfort
subjects affected / exposed	1 / 28 (3.57%)	1 / 29 (3.45%)	1 / 12 (8.33%)	0 / 11 (0.00%)	1 / 11 (9.09%)	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	2 / 35 (5.71%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	2 / 25 (8.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	1	1	0	1	1	0	0	0	0	0	0	2	0	0	0	0	0	0	2	0	0	0	0	0	0	0
Chest pain
subjects affected / exposed	1 / 28 (3.57%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	1 / 11 (9.09%)	1 / 10 (10.00%)	2 / 21 (9.52%)	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	1	0	1	0	1	1	2	1	1	0	0	1	0	0	0	0	0	2	0	0	0	0	0	1	1	1	0
Chills
subjects affected / exposed	4 / 28 (14.29%)	1 / 29 (3.45%)	1 / 12 (8.33%)	4 / 11 (36.36%)	2 / 11 (18.18%)	1 / 10 (10.00%)	6 / 21 (28.57%)	4 / 28 (14.29%)	4 / 29 (13.79%)	0 / 8 (0.00%)	0 / 12 (0.00%)	5 / 21 (23.81%)	4 / 35 (11.43%)	3 / 14 (21.43%)	2 / 11 (18.18%)	3 / 12 (25.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	2 / 10 (20.00%)	3 / 25 (12.00%)	2 / 12 (16.67%)	3 / 12 (25.00%)	3 / 7 (42.86%)	2 / 6 (33.33%)	2 / 12 (16.67%)	2 / 12 (16.67%)	4 / 7 (57.14%)
occurrences all number	4	2	1	5	2	1	7	6	4	0	0	7	5	3	2	5	0	1	2	3	2	3	6	7	2	2	7
Fatigue
subjects affected / exposed	14 / 28 (50.00%)	12 / 29 (41.38%)	7 / 12 (58.33%)	4 / 11 (36.36%)	7 / 11 (63.64%)	3 / 10 (30.00%)	9 / 21 (42.86%)	11 / 28 (39.29%)	10 / 29 (34.48%)	2 / 8 (25.00%)	5 / 12 (41.67%)	3 / 21 (14.29%)	8 / 35 (22.86%)	4 / 14 (28.57%)	2 / 11 (18.18%)	6 / 12 (50.00%)	1 / 6 (16.67%)	2 / 8 (25.00%)	3 / 10 (30.00%)	7 / 25 (28.00%)	5 / 12 (41.67%)	5 / 12 (41.67%)	4 / 7 (57.14%)	5 / 6 (83.33%)	5 / 12 (41.67%)	6 / 12 (50.00%)	6 / 7 (85.71%)
occurrences all number	17	18	9	8	8	5	11	19	14	4	6	3	12	6	2	10	1	2	4	8	9	11	6	7	5	10	6
Gait disturbance
subjects affected / exposed	1 / 28 (3.57%)	3 / 29 (10.34%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)
occurrences all number	1	3	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Feeling hot
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Influenza like illness
subjects affected / exposed	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	3 / 21 (14.29%)	2 / 28 (7.14%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 21 (4.76%)	2 / 35 (5.71%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	2 / 25 (8.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	1	0	0	0	0	3	3	0	0	0	3	3	0	0	0	0	0	0	2	0	1	0	0	1	0	0
Injection site pain
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)	2 / 6 (33.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	2	0	0	4
Localised oedema
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Malaise
subjects affected / exposed	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 12 (0.00%)	1 / 11 (9.09%)	1 / 11 (9.09%)	1 / 10 (10.00%)	0 / 21 (0.00%)	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	2 / 21 (9.52%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	2 / 6 (33.33%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)
occurrences all number	1	1	0	2	1	1	0	1	0	0	0	2	0	0	0	0	0	0	0	0	1	0	0	2	0	0	1
Non-cardiac chest pain
subjects affected / exposed	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 12 (0.00%)	3 / 11 (27.27%)	1 / 11 (9.09%)	0 / 10 (0.00%)	1 / 21 (4.76%)	1 / 28 (3.57%)	2 / 29 (6.90%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	2 / 14 (14.29%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	1 / 25 (4.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	3	1	0	1	1	4	0	0	0	0	2	0	0	0	0	1	1	0	1	0	0	0	0	0
Oedema peripheral
subjects affected / exposed	2 / 28 (7.14%)	4 / 29 (13.79%)	1 / 12 (8.33%)	0 / 11 (0.00%)	1 / 11 (9.09%)	1 / 10 (10.00%)	0 / 21 (0.00%)	1 / 28 (3.57%)	2 / 29 (6.90%)	0 / 8 (0.00%)	1 / 12 (8.33%)	2 / 21 (9.52%)	1 / 35 (2.86%)	0 / 14 (0.00%)	1 / 11 (9.09%)	1 / 12 (8.33%)	2 / 6 (33.33%)	0 / 8 (0.00%)	1 / 10 (10.00%)	2 / 25 (8.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)
occurrences all number	3	4	1	0	1	1	0	1	2	0	1	2	1	0	1	1	3	0	1	2	2	0	0	1	0	0	1
Pyrexia
subjects affected / exposed	3 / 28 (10.71%)	4 / 29 (13.79%)	0 / 12 (0.00%)	2 / 11 (18.18%)	1 / 11 (9.09%)	2 / 10 (20.00%)	2 / 21 (9.52%)	3 / 28 (10.71%)	3 / 29 (10.34%)	0 / 8 (0.00%)	2 / 12 (16.67%)	4 / 21 (19.05%)	5 / 35 (14.29%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	3	5	0	3	1	2	5	3	4	0	2	8	5	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Pain
subjects affected / exposed	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	1 / 21 (4.76%)	3 / 28 (10.71%)	1 / 29 (3.45%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	1 / 6 (16.67%)	2 / 8 (25.00%)	2 / 10 (20.00%)	2 / 25 (8.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	1	0	1	5	1	0	0	0	0	0	0	1	1	2	2	2	0	1	0	0	1	1	0
Immune system disorders
Drug hypersensitivity
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0	0	0	0	0	0	0	0
Seasonal allergy
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	2	0	0	0	0	0	0
Contrast media allergy
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Cytokine release syndrome
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 7 (28.57%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	1	0	0	3
Hypersensitivity
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Reproductive system and breast disorders
Breast pain
subjects affected / exposed	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	2 / 21 (9.52%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	2	2	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Pelvic pain
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Benign prostatic hyperplasia
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Peyronie's disease
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Testicular swelling
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Pruritus genital
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Cough
subjects affected / exposed	3 / 28 (10.71%)	8 / 29 (27.59%)	0 / 12 (0.00%)	5 / 11 (45.45%)	2 / 11 (18.18%)	1 / 10 (10.00%)	4 / 21 (19.05%)	2 / 28 (7.14%)	4 / 29 (13.79%)	0 / 8 (0.00%)	2 / 12 (16.67%)	3 / 21 (14.29%)	5 / 35 (14.29%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	5	9	0	6	4	1	4	2	4	0	2	6	5	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Dysphonia
subjects affected / exposed	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	2	1	0	1	0	0	0	0	1	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Dyspnoea
subjects affected / exposed	6 / 28 (21.43%)	8 / 29 (27.59%)	0 / 12 (0.00%)	5 / 11 (45.45%)	5 / 11 (45.45%)	4 / 10 (40.00%)	4 / 21 (19.05%)	2 / 28 (7.14%)	6 / 29 (20.69%)	0 / 8 (0.00%)	2 / 12 (16.67%)	4 / 21 (19.05%)	7 / 35 (20.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	7	15	0	7	6	4	8	2	6	0	2	5	9	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Epistaxis
subjects affected / exposed	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	1 / 21 (4.76%)	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	1	0	0	0	1	0	5	1	1	0	2	1	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Dyspnoea exertional
subjects affected / exposed	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	2 / 29 (6.90%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	1	0	0	0	0	0	0	2	0	2	1	1	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Haemoptysis
subjects affected / exposed	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	1 / 10 (10.00%)	2 / 21 (9.52%)	0 / 28 (0.00%)	3 / 29 (10.34%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	2 / 35 (5.71%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	1	0	0	1	1	3	0	3	0	2	0	2	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Hiccups
subjects affected / exposed	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	1	1	0	1	0	0	0	0	1	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Hypoventilation
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	3 / 35 (8.57%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	2	0	3	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Hypoxia
subjects affected / exposed	0 / 28 (0.00%)	4 / 29 (13.79%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	1 / 21 (4.76%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	6	0	0	0	1	3	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Laryngeal haemorrhage
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	5	0	0	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Nasal congestion
subjects affected / exposed	0 / 28 (0.00%)	2 / 29 (6.90%)	0 / 12 (0.00%)	1 / 11 (9.09%)	1 / 11 (9.09%)	0 / 10 (0.00%)	1 / 21 (4.76%)	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	2 / 21 (9.52%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	2	0	1	6	0	1	1	0	0	2	2	1	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Oropharyngeal pain
subjects affected / exposed	3 / 28 (10.71%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	2 / 28 (7.14%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	2 / 21 (9.52%)	2 / 35 (5.71%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	3	0	0	1	1	0	0	2	2	0	2	2	2	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Pneumonitis
subjects affected / exposed	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	1 / 21 (4.76%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	1	0	1	0	0	1	0	0	0	2	0	2	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Pleural effusion
subjects affected / exposed	0 / 28 (0.00%)	2 / 29 (6.90%)	0 / 12 (0.00%)	1 / 11 (9.09%)	2 / 11 (18.18%)	0 / 10 (0.00%)	2 / 21 (9.52%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	2 / 35 (5.71%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	2	0	2	2	0	2	0	0	0	2	0	3	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Productive cough
subjects affected / exposed	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	1 / 21 (4.76%)	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	1	0	0	1	0	0	1	0	1	0	2	1	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Rales
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Pulmonary embolism
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Rhinorrhoea
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	2 / 11 (18.18%)	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	3	1	0	0	0	0	2	1	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Sinus congestion
subjects affected / exposed	0 / 28 (0.00%)	2 / 29 (6.90%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	2	0	0	0	1	0	0	0	0	2	1	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Tracheal stenosis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Wheezing
subjects affected / exposed	2 / 28 (7.14%)	0 / 29 (0.00%)	0 / 12 (0.00%)	2 / 11 (18.18%)	2 / 11 (18.18%)	1 / 10 (10.00%)	1 / 21 (4.76%)	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	2	0	0	2	3	1	2	0	1	0	2	1	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Aspiration
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Bronchial hyperreactivity
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Pharyngeal inflammation
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Rhinitis allergic
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0
Sleep apnoea syndrome
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Acute respiratory failure
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Increased viscosity of bronchial secretion
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Allergic sinusitis
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Sputum increased
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0
Pharyngeal haemorrhage
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0
Dry throat
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Lung disorder
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Nasal discomfort
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Lung opacity
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Nasopharyngeal reflux
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Nasal dryness
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Pneumonitis aspiration
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Pneumothorax
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Obstructive airways disorder
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Sinus pain
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Upper-airway cough syndrome
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	1	0	0	0	0	0	0
Increased upper airway secretion
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Pleuritic pain
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1
Pulmonary pain
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Throat tightness
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Psychiatric disorders
Anxiety
subjects affected / exposed	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 12 (0.00%)	2 / 11 (18.18%)	1 / 11 (9.09%)	0 / 10 (0.00%)	2 / 21 (9.52%)	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	1	0	2	7	0	3	1	1	0	2	1	1	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Confusional state
subjects affected / exposed	1 / 28 (3.57%)	2 / 29 (6.90%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	3 / 28 (10.71%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	1	2	0	1	0	0	0	4	0	0	2	1	1	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Depression
subjects affected / exposed	0 / 28 (0.00%)	2 / 29 (6.90%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	2 / 29 (6.90%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	2 / 35 (5.71%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	2	0	0	0	0	0	0	2	0	2	1	2	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Insomnia
subjects affected / exposed	1 / 28 (3.57%)	4 / 29 (13.79%)	0 / 12 (0.00%)	0 / 11 (0.00%)	2 / 11 (18.18%)	2 / 10 (20.00%)	1 / 21 (4.76%)	2 / 28 (7.14%)	3 / 29 (10.34%)	0 / 8 (0.00%)	2 / 12 (16.67%)	2 / 21 (9.52%)	2 / 35 (5.71%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	1	4	0	0	2	2	1	2	3	0	2	2	2	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Restlessness
subjects affected / exposed	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	1	0	0	0	1	0	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Nightmare
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Agitation
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	1	0	1	0	0	0	0
Panic attack
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Generalised anxiety disorder
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Alcohol withdrawal syndrome
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Depressed mood
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Stress
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Irritability
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Anticipatory anxiety
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0
Product issues
Device occlusion
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 12 (0.00%)	3 / 11 (27.27%)	0 / 11 (0.00%)	0 / 10 (0.00%)	3 / 21 (14.29%)	1 / 28 (3.57%)	2 / 29 (6.90%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	2 / 35 (5.71%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	1	1	0	3	0	0	3	1	2	0	2	2	4	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Amylase increased
subjects affected / exposed	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 12 (0.00%)	2 / 11 (18.18%)	0 / 11 (0.00%)	1 / 10 (10.00%)	2 / 21 (9.52%)	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	1	2	0	3	0	2	3	1	2	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Aspartate aminotransferase increased
subjects affected / exposed	3 / 28 (10.71%)	1 / 29 (3.45%)	0 / 12 (0.00%)	4 / 11 (36.36%)	1 / 11 (9.09%)	0 / 10 (0.00%)	3 / 21 (14.29%)	2 / 28 (7.14%)	2 / 29 (6.90%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	4 / 35 (11.43%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	3	1	0	4	1	0	3	2	3	0	2	2	6	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Blood alkaline phosphatase increased
subjects affected / exposed	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	1 / 28 (3.57%)	2 / 29 (6.90%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	2 / 35 (5.71%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	1	1	0	1	0	0	0	5	2	0	2	2	3	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Blood calcium increased
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Blood creatine phosphokinase increased
subjects affected / exposed	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	1 / 21 (4.76%)	2 / 28 (7.14%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	3 / 35 (8.57%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	4	2	0	0	0	0	1	3	0	0	2	1	3	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Blood creatinine increased
subjects affected / exposed	2 / 28 (7.14%)	1 / 29 (3.45%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	2 / 10 (20.00%)	2 / 21 (9.52%)	2 / 28 (7.14%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	4	1	0	1	0	2	2	2	0	0	2	0	1	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Blood pressure increased
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
C-reactive protein increased
subjects affected / exposed	0 / 28 (0.00%)	3 / 29 (10.34%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	2 / 28 (7.14%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	3	0	2	0	0	0	2	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Electrocardiogram QT prolonged
subjects affected / exposed	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	2	0	0	0	1	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Gamma-glutamyltransferase increased
subjects affected / exposed	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 12 (0.00%)	1 / 11 (9.09%)	1 / 11 (9.09%)	0 / 10 (0.00%)	1 / 21 (4.76%)	2 / 28 (7.14%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	3 / 35 (8.57%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	1	1	0	3	1	0	1	3	1	0	2	2	4	3	2	0	1	1	2	2	2	1	8	6	1	7	4
International normalised ratio increased
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Lipase increased
subjects affected / exposed	4 / 28 (14.29%)	1 / 29 (3.45%)	0 / 12 (0.00%)	2 / 11 (18.18%)	0 / 11 (0.00%)	2 / 10 (20.00%)	1 / 21 (4.76%)	5 / 28 (17.86%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	4	8	0	2	0	4	1	10	1	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Lymphocyte count decreased
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	2 / 11 (18.18%)	0 / 11 (0.00%)	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	3	0	1	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Platelet count decreased
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	0 / 21 (0.00%)	2 / 28 (7.14%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	0	1	0	2	0	0	2	2	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Weight decreased
subjects affected / exposed	5 / 28 (17.86%)	4 / 29 (13.79%)	0 / 12 (0.00%)	3 / 11 (27.27%)	0 / 11 (0.00%)	3 / 10 (30.00%)	1 / 21 (4.76%)	2 / 28 (7.14%)	3 / 29 (10.34%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	3 / 35 (8.57%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	5	5	0	3	0	8	2	2	3	0	2	0	3	3	2	0	1	1	2	2	2	1	8	6	1	7	4
White blood cell count decreased
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	2 / 28 (7.14%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	0	0	0	3	0	0	2	1	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Weight increased
subjects affected / exposed	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	2	0	0	2	0	0	0	3	0	2	0	5	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Blood glucose increased
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Blood cholesterol increased
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 8 (12.50%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Blood lactate dehydrogenase increased
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0
Blood uric acid increased
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Body temperature increased
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Cardiac murmur
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Haemoglobin decreased
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0
Liver function test increased
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Eosinophil count increased
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Lymph node palpable
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Urine output decreased
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Blood creatine phosphokinase
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Amylase
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Blood corticotrophin decreased
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Blood corticotrophin increased
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Blood thyroid stimulating hormone increased
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Blood urea increased
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Pancreatic enzymes increased
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
SARS-CoV-2 test positive
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0
Injury, poisoning and procedural complications
Contusion
subjects affected / exposed	2 / 28 (7.14%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	1 / 21 (4.76%)	0 / 28 (0.00%)	2 / 29 (6.90%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	2	1	0	0	0	0	1	0	2	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Infusion related reaction
subjects affected / exposed	4 / 28 (14.29%)	7 / 29 (24.14%)	0 / 12 (0.00%)	2 / 11 (18.18%)	1 / 11 (9.09%)	2 / 10 (20.00%)	1 / 21 (4.76%)	3 / 28 (10.71%)	10 / 29 (34.48%)	0 / 8 (0.00%)	2 / 12 (16.67%)	3 / 21 (14.29%)	3 / 35 (8.57%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	8	9	0	2	1	2	2	3	11	0	2	4	3	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Fall
subjects affected / exposed	4 / 28 (14.29%)	4 / 29 (13.79%)	0 / 12 (0.00%)	3 / 11 (27.27%)	2 / 11 (18.18%)	2 / 10 (20.00%)	4 / 21 (19.05%)	0 / 28 (0.00%)	2 / 29 (6.90%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	7	4	0	4	2	3	4	0	7	0	2	1	1	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Ligament sprain
subjects affected / exposed	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	1	0	0	0	1	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Skin abrasion
subjects affected / exposed	0 / 28 (0.00%)	2 / 29 (6.90%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	2	0	0	0	0	0	0	1	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Incision site erythema
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Head injury
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Procedural pain
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	2 / 14 (14.29%)	1 / 11 (9.09%)	1 / 12 (8.33%)	2 / 6 (33.33%)	1 / 8 (12.50%)	0 / 10 (0.00%)	1 / 25 (4.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	2	1	1	2	1	0	1	0	0	0	1	0	1	0
Spinal fracture
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Muscle strain
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Rib fracture
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0
Arthropod sting
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Periorbital haematoma
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Sunburn
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Tracheostomy malfunction
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Incision site haemorrhage
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Wound haemorrhage
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Wound complication
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Wound
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Cardiac disorders
Atrial thrombosis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Atrial fibrillation
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0
Ventricular tachycardia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Cardiac valve disease
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Myocardial infarction
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Pericardial effusion
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Supraventricular tachycardia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0	0	0	0	0	0	0	0	0
Myocarditis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Pulseless electrical activity
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Angina pectoris
subjects affected / exposed	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Bradycardia
subjects affected / exposed	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	1	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Sinus bradycardia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Sinus tachycardia
subjects affected / exposed	0 / 28 (0.00%)	2 / 29 (6.90%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 8 (0.00%)	0 / 12 (0.00%)	2 / 21 (9.52%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	1 / 6 (16.67%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	1	0	0	2	0	0	0	1	1	0	1	0	0	0	0	0	0	0	0
Tachycardia
subjects affected / exposed	4 / 28 (14.29%)	2 / 29 (6.90%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	1 / 21 (4.76%)	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 8 (0.00%)	0 / 12 (0.00%)	3 / 21 (14.29%)	2 / 35 (5.71%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)
occurrences all number	4	3	0	0	0	0	1	1	1	0	0	3	2	0	0	0	0	0	0	0	0	0	1	1	0	0	1
Nervous system disorders
Brain oedema
subjects affected / exposed	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	2 / 29 (6.90%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	1	0	0	0	0	0	0	2	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Headache
subjects affected / exposed	6 / 28 (21.43%)	1 / 29 (3.45%)	0 / 12 (0.00%)	4 / 11 (36.36%)	4 / 11 (36.36%)	1 / 10 (10.00%)	3 / 21 (14.29%)	2 / 28 (7.14%)	5 / 29 (17.24%)	0 / 8 (0.00%)	2 / 12 (16.67%)	2 / 21 (9.52%)	4 / 35 (11.43%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	6	1	0	6	7	1	3	2	6	0	2	2	5	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Dysgeusia
subjects affected / exposed	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 12 (0.00%)	1 / 11 (9.09%)	1 / 11 (9.09%)	1 / 10 (10.00%)	3 / 21 (14.29%)	0 / 28 (0.00%)	3 / 29 (10.34%)	0 / 8 (0.00%)	2 / 12 (16.67%)	2 / 21 (9.52%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	1	1	0	1	1	1	3	0	3	0	2	2	1	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Dizziness
subjects affected / exposed	3 / 28 (10.71%)	3 / 29 (10.34%)	0 / 12 (0.00%)	2 / 11 (18.18%)	1 / 11 (9.09%)	1 / 10 (10.00%)	3 / 21 (14.29%)	2 / 28 (7.14%)	3 / 29 (10.34%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	5 / 35 (14.29%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	4	4	0	3	1	1	3	2	4	0	2	1	5	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Intention tremor
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Lethargy
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	3 / 35 (8.57%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	2	0	4	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Neuropathy peripheral
subjects affected / exposed	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	2 / 35 (5.71%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	1	0	0	0	0	0	1	0	0	2	0	2	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Paraesthesia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	1 / 11 (9.09%)	1 / 10 (10.00%)	1 / 21 (4.76%)	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	2 / 35 (5.71%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	1	1	1	1	1	1	0	2	1	3	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Syncope
subjects affected / exposed	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	2 / 21 (9.52%)	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	1	1	0	0	0	0	2	2	0	0	2	0	1	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Hypersomnia
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Loss of consciousness
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 8 (12.50%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hypoaesthesia
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0
Peripheral sensory neuropathy
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0
Taste disorder
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 8 (12.50%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Somnolence
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Restless legs syndrome
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0
Amnesia
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Balance disorder
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	1	0	0	0	0	0	0	0	0	0
Aphasia
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0
Dysmetria
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Central nervous system lesion
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Dizziness exertional
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Dysarthria
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Encephalopathy
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Facial paralysis
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Hyperaesthesia
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Neuralgia
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Superior sagittal sinus thrombosis
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Tremor
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Cognitive disorder
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Peroneal nerve palsy
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Memory impairment
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1
Blood and lymphatic system disorders
Neutropenia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0	9	0	0	0
Lymphadenopathy
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0
Pancytopenia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Immune thrombocytopenia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Lymphopenia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0
Leukopenia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Normocytic anaemia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Anaemia
alternative assessment type: Systematic
subjects affected / exposed	4 / 28 (14.29%)	1 / 29 (3.45%)	1 / 12 (8.33%)	3 / 11 (27.27%)	1 / 11 (9.09%)	1 / 10 (10.00%)	2 / 21 (9.52%)	1 / 28 (3.57%)	2 / 29 (6.90%)	1 / 8 (12.50%)	3 / 12 (25.00%)	2 / 21 (9.52%)	6 / 35 (17.14%)	2 / 14 (14.29%)	2 / 11 (18.18%)	1 / 12 (8.33%)	0 / 6 (0.00%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)	1 / 6 (16.67%)	2 / 12 (16.67%)	2 / 12 (16.67%)	3 / 7 (42.86%)
occurrences all number	5	2	3	4	1	1	2	1	2	1	9	3	8	3	2	1	0	1	1	1	2	3	3	4	2	2	5
Increased tendency to bruise
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	1 / 21 (4.76%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Iron deficiency anaemia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Leukocytosis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	2 / 29 (6.90%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	2	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0
Thrombocytopenia
subjects affected / exposed	0 / 28 (0.00%)	2 / 29 (6.90%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	2 / 28 (7.14%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	4	0	0	0	0	0	4	0	0	0	0	1	3	0	0	0	0	0	0	2	0	0	0	2	0	0
Ear and labyrinth disorders
Cerumen impaction
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	1 / 21 (4.76%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	2 / 21 (9.52%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Deafness
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Ear pain
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	1 / 12 (8.33%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0	0	0	0	1	0	1	0	1	1	0	0	0	0	0	1	0	0	0	0
Ear discomfort
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	1 / 21 (4.76%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	2 / 25 (8.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	2	0	1	0	0	0	0	0
Eye disorders
Cataract
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0
Eye irritation
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0
Ocular discomfort
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Periorbital oedema
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	2 / 6 (33.33%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	1	0	0	0	0	1	0	0	0	0
Eye oedema
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Photophobia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Swelling of eyelid
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Visual field defect
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Visual impairment
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0
Eye pruritus
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	1	0
Blepharitis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Eye swelling
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Pterygium
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Dry eye
alternative assessment type: Systematic
subjects affected / exposed	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	2 / 28 (7.14%)	1 / 29 (3.45%)	0 / 8 (0.00%)	0 / 12 (0.00%)	2 / 21 (9.52%)	1 / 35 (2.86%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	1	0	0	2	1	0	0	3	1	0	1	0	0	0	0	0	0	0	0	0	0	2	0
Diplopia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Vision blurred
subjects affected / exposed	0 / 28 (0.00%)	2 / 29 (6.90%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	2 / 8 (25.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	2	0	0	1	0	0	0	0	0	0	0	1	0	0	0	1	2	1	0	0	0	0	0	1	0	0
Gastrointestinal disorders
Abdominal discomfort
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Angular cheilitis
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Cheilitis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Colitis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Dental caries
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Dyspepsia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	1 / 8 (12.50%)	1 / 10 (10.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	2	1	0	0	0	0	0	1	0	0
Flatulence
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	1 / 25 (4.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Glossodynia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	1	0	0	0	0	0	0
Gastritis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Odynophagia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0
Rectal haemorrhage
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Oral pain
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Ascites
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Mouth haemorrhage
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0
Paraesthesia oral
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Oral dysaesthesia
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0
Inguinal hernia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Melaena
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Tongue disorder
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Tooth discolouration
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Anal pruritus
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Gingival bleeding
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Lip dry
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Small intestinal obstruction
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Salivary hypersecretion
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	2 / 7 (28.57%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0
Gastrointestinal pain
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 8 (12.50%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Abdominal distension
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	0 / 21 (0.00%)	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	1	0	1	1	0	0	0	0	0	0	0	1	0	1	0	0	0	0	1	1	0	1
Abdominal pain
alternative assessment type: Systematic
subjects affected / exposed	2 / 28 (7.14%)	0 / 29 (0.00%)	3 / 12 (25.00%)	2 / 11 (18.18%)	2 / 11 (18.18%)	0 / 10 (0.00%)	4 / 21 (19.05%)	5 / 28 (17.86%)	4 / 29 (13.79%)	1 / 8 (12.50%)	1 / 12 (8.33%)	1 / 21 (4.76%)	2 / 35 (5.71%)	2 / 14 (14.29%)	3 / 11 (27.27%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	1 / 10 (10.00%)	4 / 25 (16.00%)	1 / 12 (8.33%)	2 / 12 (16.67%)	0 / 7 (0.00%)	0 / 6 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	1 / 7 (14.29%)
occurrences all number	3	0	4	4	2	0	5	5	4	1	1	2	2	3	4	0	1	0	1	5	1	2	0	0	4	0	1
Abdominal pain lower
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	2	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Abdominal pain upper
subjects affected / exposed	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	1 / 10 (10.00%)	2 / 21 (9.52%)	1 / 28 (3.57%)	2 / 29 (6.90%)	0 / 8 (0.00%)	0 / 12 (0.00%)	2 / 21 (9.52%)	1 / 35 (2.86%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)
occurrences all number	1	0	0	1	0	2	2	1	2	0	0	2	1	0	0	0	0	0	1	0	0	0	1	0	0	0	1
Constipation
subjects affected / exposed	4 / 28 (14.29%)	8 / 29 (27.59%)	3 / 12 (25.00%)	1 / 11 (9.09%)	3 / 11 (27.27%)	2 / 10 (20.00%)	5 / 21 (23.81%)	8 / 28 (28.57%)	4 / 29 (13.79%)	1 / 8 (12.50%)	4 / 12 (33.33%)	3 / 21 (14.29%)	6 / 35 (17.14%)	2 / 14 (14.29%)	0 / 11 (0.00%)	1 / 12 (8.33%)	1 / 6 (16.67%)	2 / 8 (25.00%)	1 / 10 (10.00%)	5 / 25 (20.00%)	4 / 12 (33.33%)	3 / 12 (25.00%)	5 / 7 (71.43%)	0 / 6 (0.00%)	0 / 12 (0.00%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	4	12	3	1	4	2	6	8	6	1	4	4	6	2	0	2	1	2	1	6	6	3	5	0	0	2	2
Diarrhoea
subjects affected / exposed	5 / 28 (17.86%)	6 / 29 (20.69%)	2 / 12 (16.67%)	2 / 11 (18.18%)	3 / 11 (27.27%)	2 / 10 (20.00%)	6 / 21 (28.57%)	5 / 28 (17.86%)	6 / 29 (20.69%)	4 / 8 (50.00%)	1 / 12 (8.33%)	4 / 21 (19.05%)	7 / 35 (20.00%)	6 / 14 (42.86%)	2 / 11 (18.18%)	3 / 12 (25.00%)	2 / 6 (33.33%)	1 / 8 (12.50%)	2 / 10 (20.00%)	4 / 25 (16.00%)	2 / 12 (16.67%)	5 / 12 (41.67%)	4 / 7 (57.14%)	3 / 6 (50.00%)	2 / 12 (16.67%)	4 / 12 (33.33%)	1 / 7 (14.29%)
occurrences all number	7	9	3	6	6	2	10	5	6	5	1	4	10	8	2	5	7	1	2	11	2	8	4	3	2	8	1
Dry mouth
subjects affected / exposed	5 / 28 (17.86%)	0 / 29 (0.00%)	0 / 12 (0.00%)	2 / 11 (18.18%)	1 / 11 (9.09%)	0 / 10 (0.00%)	1 / 21 (4.76%)	3 / 28 (10.71%)	3 / 29 (10.34%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 21 (4.76%)	2 / 35 (5.71%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	5	0	0	3	1	0	1	3	4	0	0	1	2	1	0	0	1	1	0	0	2	1	0	0	0	0	0
Dysphagia
subjects affected / exposed	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	2 / 21 (9.52%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	2 / 8 (25.00%)	1 / 10 (10.00%)	3 / 25 (12.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	3 / 7 (42.86%)	0 / 6 (0.00%)	1 / 12 (8.33%)	3 / 12 (25.00%)	1 / 7 (14.29%)
occurrences all number	1	1	0	1	0	0	0	0	0	0	0	2	0	0	0	0	1	2	1	3	0	0	3	0	1	3	1
Gastrooesophageal reflux disease
subjects affected / exposed	3 / 28 (10.71%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	2 / 21 (9.52%)	1 / 28 (3.57%)	3 / 29 (10.34%)	0 / 8 (0.00%)	0 / 12 (0.00%)	2 / 21 (9.52%)	3 / 35 (8.57%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	3	1	0	0	0	0	2	1	3	0	0	2	3	0	0	0	0	0	0	0	0	1	0	0	2	0	0
Haemorrhoidal haemorrhage
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Haematochezia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Nausea
subjects affected / exposed	9 / 28 (32.14%)	7 / 29 (24.14%)	5 / 12 (41.67%)	3 / 11 (27.27%)	5 / 11 (45.45%)	3 / 10 (30.00%)	9 / 21 (42.86%)	8 / 28 (28.57%)	8 / 29 (27.59%)	1 / 8 (12.50%)	1 / 12 (8.33%)	4 / 21 (19.05%)	2 / 35 (5.71%)	4 / 14 (28.57%)	3 / 11 (27.27%)	3 / 12 (25.00%)	3 / 6 (50.00%)	3 / 8 (37.50%)	2 / 10 (20.00%)	6 / 25 (24.00%)	3 / 12 (25.00%)	0 / 12 (0.00%)	3 / 7 (42.86%)	4 / 6 (66.67%)	3 / 12 (25.00%)	3 / 12 (25.00%)	2 / 7 (28.57%)
occurrences all number	11	10	6	12	7	3	11	11	10	1	1	4	5	6	3	7	3	4	2	12	4	0	5	7	3	4	2
Lip disorder
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Haemorrhoids
subjects affected / exposed	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	1 / 21 (4.76%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	1	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Stomatitis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	3 / 21 (14.29%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	2 / 12 (16.67%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0	3	0	0	0	1	1	0	0	0	3	0	0	0	0	0	0
Oesophagitis
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	1 / 21 (4.76%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	2 / 35 (5.71%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Oesophageal spasm
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Toothache
subjects affected / exposed	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	1 / 21 (4.76%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	1	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0
Vomiting
subjects affected / exposed	7 / 28 (25.00%)	5 / 29 (17.24%)	4 / 12 (33.33%)	4 / 11 (36.36%)	2 / 11 (18.18%)	1 / 10 (10.00%)	4 / 21 (19.05%)	6 / 28 (21.43%)	6 / 29 (20.69%)	2 / 8 (25.00%)	0 / 12 (0.00%)	6 / 21 (28.57%)	7 / 35 (20.00%)	5 / 14 (35.71%)	3 / 11 (27.27%)	3 / 12 (25.00%)	4 / 6 (66.67%)	2 / 8 (25.00%)	3 / 10 (30.00%)	3 / 25 (12.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	2 / 7 (28.57%)	3 / 6 (50.00%)	4 / 12 (33.33%)	2 / 12 (16.67%)	1 / 7 (14.29%)
occurrences all number	8	6	5	5	2	1	6	6	6	2	0	9	9	6	3	5	4	4	4	3	1	0	3	9	6	3	1
Hepatobiliary disorders
Hyperbilirubinaemia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Hepatitis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	4	0	0
Skin and subcutaneous tissue disorders
Dry skin
subjects affected / exposed	4 / 28 (14.29%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	1 / 21 (4.76%)	1 / 28 (3.57%)	2 / 29 (6.90%)	0 / 8 (0.00%)	2 / 12 (16.67%)	3 / 21 (14.29%)	2 / 35 (5.71%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	5	1	0	0	0	1	1	1	2	0	2	4	2	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Dermatitis contact
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Dermatitis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	2 / 35 (5.71%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	2	0	2	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Erythema
subjects affected / exposed	0 / 28 (0.00%)	2 / 29 (6.90%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	1 / 10 (10.00%)	1 / 21 (4.76%)	2 / 28 (7.14%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	2	0	0	1	1	1	2	0	0	2	1	1	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Hirsutism
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Night sweats
subjects affected / exposed	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	1 / 21 (4.76%)	0 / 28 (0.00%)	2 / 29 (6.90%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	1	0	0	1	0	0	1	0	2	0	2	0	1	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Pruritus
subjects affected / exposed	7 / 28 (25.00%)	2 / 29 (6.90%)	0 / 12 (0.00%)	2 / 11 (18.18%)	3 / 11 (27.27%)	3 / 10 (30.00%)	2 / 21 (9.52%)	4 / 28 (14.29%)	7 / 29 (24.14%)	0 / 8 (0.00%)	2 / 12 (16.67%)	3 / 21 (14.29%)	4 / 35 (11.43%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	9	2	0	2	4	5	2	4	7	0	2	5	5	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Rash erythematous
subjects affected / exposed	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	2 / 28 (7.14%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	1	0	2	0	0	0	2	1	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Rash
subjects affected / exposed	4 / 28 (14.29%)	1 / 29 (3.45%)	0 / 12 (0.00%)	3 / 11 (27.27%)	1 / 11 (9.09%)	0 / 10 (0.00%)	2 / 21 (9.52%)	4 / 28 (14.29%)	3 / 29 (10.34%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	2 / 35 (5.71%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	7	1	0	3	1	0	2	6	3	0	2	0	2	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Rash maculo-papular
subjects affected / exposed	2 / 28 (7.14%)	2 / 29 (6.90%)	0 / 12 (0.00%)	1 / 11 (9.09%)	3 / 11 (27.27%)	1 / 10 (10.00%)	1 / 21 (4.76%)	2 / 28 (7.14%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	2 / 21 (9.52%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	3	2	0	1	11	1	1	4	3	0	2	3	1	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Skin ulcer
subjects affected / exposed	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	1	0	1	0	0	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Rash pruritic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	2 / 11 (18.18%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	4 / 28 (14.29%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	2	0	0	0	4	0	0	2	0	1	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Skin disorder
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Alopecia
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	1 / 25 (4.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0
Hyperhidrosis
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	2 / 14 (14.29%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	1	0	0	0	0	0
Cold sweat
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Pain of skin
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0
Pemphigoid
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 8 (12.50%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Rash papular
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Dermatitis acneiform
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	2 / 6 (33.33%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	1	1	0	0	0	0	0
Blister
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Lichenoid keratosis
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Hidradenitis
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Petechiae
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0
Actinic keratosis
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Stasis dermatitis
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Butterfly rash
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Miliaria
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Ingrowing nail
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Nail discolouration
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Nail pitting
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Papule
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Onychoclasis
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0
Prurigo
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Psoriasis
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0
Rash macular
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Skin exfoliation
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0
Skin fissures
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Skin lesion
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Vitiligo
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0
Skin irritation
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Exfoliative rash
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Renal and urinary disorders
Proteinuria
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Pollakiuria
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	2 / 35 (5.71%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	2	0	0	0	0	1	0	2	1	2	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Haematuria
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	2 / 28 (7.14%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	0	0	0	2	1	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Acute kidney injury
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Dysuria
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Hydronephrosis
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Nephritis
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Urinary hesitation
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Micturition urgency
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Bladder spasm
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Nocturia
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Chronic kidney disease
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Urinary retention
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Urinary tract obstruction
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Endocrine disorders
Adrenal insufficiency
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Secondary hypogonadism
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Hyperthyroidism
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	1 / 21 (4.76%)	2 / 28 (7.14%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	1	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hypothyroidism
subjects affected / exposed	1 / 28 (3.57%)	4 / 29 (13.79%)	0 / 12 (0.00%)	1 / 11 (9.09%)	3 / 11 (27.27%)	1 / 10 (10.00%)	1 / 21 (4.76%)	2 / 28 (7.14%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	5 / 35 (14.29%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	0 / 10 (0.00%)	2 / 25 (8.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	2 / 12 (16.67%)	0 / 7 (0.00%)
occurrences all number	2	5	0	1	3	1	1	3	0	0	0	0	6	0	0	0	1	1	0	2	3	1	0	1	0	2	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	4 / 28 (14.29%)	4 / 29 (13.79%)	0 / 12 (0.00%)	4 / 11 (36.36%)	4 / 11 (36.36%)	1 / 10 (10.00%)	5 / 21 (23.81%)	3 / 28 (10.71%)	7 / 29 (24.14%)	0 / 8 (0.00%)	2 / 12 (16.67%)	4 / 21 (19.05%)	3 / 35 (8.57%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	9	6	0	13	6	2	5	4	8	0	2	4	3	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Arthritis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Arthropathy
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Back pain
subjects affected / exposed	3 / 28 (10.71%)	3 / 29 (10.34%)	0 / 12 (0.00%)	5 / 11 (45.45%)	3 / 11 (27.27%)	0 / 10 (0.00%)	4 / 21 (19.05%)	5 / 28 (17.86%)	10 / 29 (34.48%)	0 / 8 (0.00%)	2 / 12 (16.67%)	7 / 21 (33.33%)	4 / 35 (11.43%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	7	4	0	10	6	0	4	5	13	0	2	7	6	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Bone pain
subjects affected / exposed	0 / 28 (0.00%)	2 / 29 (6.90%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	2 / 21 (9.52%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	2	0	0	0	0	0	0	1	0	2	2	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Costochondritis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Flank pain
subjects affected / exposed	0 / 28 (0.00%)	3 / 29 (10.34%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	1 / 21 (4.76%)	0 / 28 (0.00%)	4 / 29 (13.79%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	3	0	0	0	0	1	0	4	0	2	1	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Joint stiffness
subjects affected / exposed	0 / 28 (0.00%)	3 / 29 (10.34%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	3	0	1	0	0	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Joint swelling
subjects affected / exposed	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	2 / 29 (6.90%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	2 / 35 (5.71%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	1	0	0	0	0	0	0	0	3	0	2	0	3	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Muscle spasms
subjects affected / exposed	0 / 28 (0.00%)	3 / 29 (10.34%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	2 / 21 (9.52%)	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	3 / 21 (14.29%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	3	0	0	0	0	3	0	3	0	2	3	1	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Muscular weakness
subjects affected / exposed	2 / 28 (7.14%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	1 / 21 (4.76%)	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	2 / 21 (9.52%)	2 / 35 (5.71%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	2	0	0	0	0	2	1	0	1	0	2	2	2	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Musculoskeletal chest pain
subjects affected / exposed	2 / 28 (7.14%)	1 / 29 (3.45%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	2 / 21 (9.52%)	1 / 28 (3.57%)	2 / 29 (6.90%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	2	1	0	1	0	0	2	2	2	0	2	0	1	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Musculoskeletal pain
subjects affected / exposed	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	1 / 10 (10.00%)	0 / 21 (0.00%)	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	2	0	0	1	1	0	1	2	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Myalgia
subjects affected / exposed	3 / 28 (10.71%)	3 / 29 (10.34%)	0 / 12 (0.00%)	1 / 11 (9.09%)	2 / 11 (18.18%)	0 / 10 (0.00%)	2 / 21 (9.52%)	0 / 28 (0.00%)	3 / 29 (10.34%)	0 / 8 (0.00%)	2 / 12 (16.67%)	4 / 21 (19.05%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	4	4	0	1	2	0	6	0	3	0	2	5	1	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Neck pain
subjects affected / exposed	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	4 / 21 (19.05%)	3 / 28 (10.71%)	2 / 29 (6.90%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	5 / 35 (14.29%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	2	0	0	1	0	5	3	2	0	2	0	6	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Osteoarthritis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	2	0	1	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Pain in extremity
subjects affected / exposed	3 / 28 (10.71%)	3 / 29 (10.34%)	0 / 12 (0.00%)	4 / 11 (36.36%)	1 / 11 (9.09%)	1 / 10 (10.00%)	1 / 21 (4.76%)	1 / 28 (3.57%)	3 / 29 (10.34%)	0 / 8 (0.00%)	2 / 12 (16.67%)	3 / 21 (14.29%)	2 / 35 (5.71%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	3	4	0	8	2	1	1	1	4	0	2	3	3	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Pain in jaw
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	1	0	0	1	1	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Scleroderma
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Trismus
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	2 / 35 (5.71%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	2	0	2	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Tendonitis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	0	1	0	0	1	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Groin pain
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Muscle tightness
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Limb discomfort
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Musculoskeletal discomfort
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 12 (8.33%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Limb mass
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Neck mass
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Osteoporosis
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Periarthritis
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Spinal pain
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Infections and infestations
Fungal foot infection
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Eye infection
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Nail infection
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Gastroenteritis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Herpes zoster
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Lower respiratory tract infection
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0
Rhinitis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Peritonitis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Paronychia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Vaginal infection
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Appendicitis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Genital herpes
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Sepsis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	1
Catheter site infection
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0
Catheter site cellulitis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Pilonidal disease
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0
Cellulitis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	1	0
Fungal infection
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Herpes dermatitis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Hordeolum
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Penile infection
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Pneumonia aspiration
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	2 / 12 (16.67%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	1	0	0	0	0	1
Infected skin ulcer
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Sialoadenitis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Tracheitis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Staphylococcal skin infection
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Subcutaneous abscess
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Postoperative wound infection
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Candida infection
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 21 (4.76%)	2 / 35 (5.71%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	2	0	0	0	2	0	0	0	0	0	0	0	0	0	0
Bronchitis
subjects affected / exposed	0 / 28 (0.00%)	4 / 29 (13.79%)	0 / 12 (0.00%)	1 / 11 (9.09%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	5	0	1	1	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Diverticulitis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	2	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Furuncle
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Gingivitis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Conjunctivitis
subjects affected / exposed	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	1	0	0	3	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	1	0
Lip infection
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Lyme disease
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Oral candidiasis
subjects affected / exposed	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 21 (0.00%)	2 / 35 (5.71%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	0 / 25 (0.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	2	0	1	0	2	0	0	0	0	1	0	0	2	1	0	0	0	0	0
Nasopharyngitis
subjects affected / exposed	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	3 / 28 (10.71%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	1 / 14 (7.14%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	2 / 25 (8.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	1	0	0	1	0	0	5	0	0	0	0	1	1	3	0	0	0	0	3	1	0	0	0	0	0	0
Otitis media
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Oral herpes
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Pneumonia
subjects affected / exposed	2 / 28 (7.14%)	2 / 29 (6.90%)	0 / 12 (0.00%)	1 / 11 (9.09%)	2 / 11 (18.18%)	0 / 10 (0.00%)	0 / 21 (0.00%)	1 / 28 (3.57%)	1 / 29 (3.45%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 21 (4.76%)	1 / 35 (2.86%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	3 / 25 (12.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	1 / 7 (14.29%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	2	2	0	1	2	0	0	1	1	0	0	1	1	1	0	0	1	0	0	4	1	0	4	2	0	0	0
Rash pustular
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Skin infection
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	1 / 21 (4.76%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	2 / 25 (8.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	2	0	0	0	1	0	0	0	1	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0
Sinusitis
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	2 / 11 (18.18%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	2 / 25 (8.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)	1 / 6 (16.67%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	3	0	0	0	0	0	0	0	0	3	0	0	0	0	0	0	2	0	0	1	1	1	0	0
Respiratory tract infection
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	2 / 35 (5.71%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Tooth infection
subjects affected / exposed	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	1 / 35 (2.86%)	0 / 14 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	1	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Upper respiratory tract infection
subjects affected / exposed	5 / 28 (17.86%)	2 / 29 (6.90%)	0 / 12 (0.00%)	2 / 11 (18.18%)	2 / 11 (18.18%)	1 / 10 (10.00%)	0 / 21 (0.00%)	1 / 28 (3.57%)	3 / 29 (10.34%)	0 / 8 (0.00%)	0 / 12 (0.00%)	3 / 21 (14.29%)	2 / 35 (5.71%)	1 / 14 (7.14%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 6 (0.00%)	1 / 8 (12.50%)	0 / 10 (0.00%)	1 / 25 (4.00%)	1 / 12 (8.33%)	3 / 12 (25.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	1 / 7 (14.29%)
occurrences all number	9	2	0	2	3	1	0	1	6	0	0	9	2	1	0	1	0	2	0	1	3	3	1	0	1	2	1
Urinary tract infection
subjects affected / exposed	2 / 28 (7.14%)	1 / 29 (3.45%)	1 / 12 (8.33%)	2 / 11 (18.18%)	2 / 11 (18.18%)	0 / 10 (0.00%)	2 / 21 (9.52%)	3 / 28 (10.71%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	2 / 21 (9.52%)	0 / 35 (0.00%)	1 / 14 (7.14%)	1 / 11 (9.09%)	1 / 12 (8.33%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	1 / 12 (8.33%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	3	1	4	3	4	0	2	3	0	0	2	3	0	1	2	1	1	0	0	0	1	1	0	0	0	0	0
Urinary tract infection staphylococcal
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Herpes simplex
subjects affected / exposed	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 6 (16.67%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Viral infection
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	2 / 29 (6.90%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	4 / 28 (14.29%)	5 / 29 (17.24%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	2 / 21 (9.52%)	2 / 28 (7.14%)	3 / 29 (10.34%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	5	6	0	0	0	1	2	2	3	0	2	1	1	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Decreased appetite
subjects affected / exposed	3 / 28 (10.71%)	9 / 29 (31.03%)	0 / 12 (0.00%)	3 / 11 (27.27%)	2 / 11 (18.18%)	6 / 10 (60.00%)	6 / 21 (28.57%)	2 / 28 (7.14%)	5 / 29 (17.24%)	0 / 8 (0.00%)	2 / 12 (16.67%)	4 / 21 (19.05%)	5 / 35 (14.29%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	6	10	0	3	3	7	7	3	6	0	2	4	6	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Hypercalcaemia
subjects affected / exposed	4 / 28 (14.29%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	1 / 21 (4.76%)	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	3 / 35 (8.57%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	6	0	0	3	0	0	1	0	1	0	2	0	7	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Hyperglycaemia
subjects affected / exposed	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 12 (0.00%)	1 / 11 (9.09%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	1	0	1	7	0	0	0	0	0	2	2	1	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Hypermagnesaemia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	1 / 10 (10.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	0	1	0	0	3	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Hypernatraemia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	4	0	0	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Hypocalcaemia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	1 / 11 (9.09%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	0 / 35 (0.00%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	2	0	0	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Hypoglycaemia
subjects affected / exposed	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	0 / 21 (0.00%)	1 / 28 (3.57%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	1	0	0	0	1	0	0	1	0	0	2	0	1	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Hypokalaemia
subjects affected / exposed	1 / 28 (3.57%)	4 / 29 (13.79%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	3 / 10 (30.00%)	1 / 21 (4.76%)	3 / 28 (10.71%)	3 / 29 (10.34%)	0 / 8 (0.00%)	2 / 12 (16.67%)	3 / 21 (14.29%)	5 / 35 (14.29%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	1	5	0	0	0	6	1	4	3	0	2	3	6	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Hypomagnesaemia
subjects affected / exposed	2 / 28 (7.14%)	1 / 29 (3.45%)	0 / 12 (0.00%)	2 / 11 (18.18%)	1 / 11 (9.09%)	1 / 10 (10.00%)	2 / 21 (9.52%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	2 / 12 (16.67%)	0 / 21 (0.00%)	3 / 35 (8.57%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	2	1	0	3	1	1	2	0	0	0	2	0	3	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Hyponatraemia
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	1 / 11 (9.09%)	0 / 10 (0.00%)	2 / 21 (9.52%)	0 / 28 (0.00%)	2 / 29 (6.90%)	0 / 8 (0.00%)	2 / 12 (16.67%)	2 / 21 (9.52%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	0	0	0	1	0	2	0	2	0	2	2	1	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Hypophosphataemia
subjects affected / exposed	0 / 28 (0.00%)	4 / 29 (13.79%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	2 / 21 (9.52%)	0 / 28 (0.00%)	1 / 29 (3.45%)	0 / 8 (0.00%)	2 / 12 (16.67%)	1 / 21 (4.76%)	1 / 35 (2.86%)	3 / 14 (21.43%)	2 / 11 (18.18%)	0 / 12 (0.00%)	1 / 6 (16.67%)	1 / 8 (12.50%)	1 / 10 (10.00%)	1 / 25 (4.00%)	2 / 12 (16.67%)	1 / 12 (8.33%)	2 / 7 (28.57%)	2 / 6 (33.33%)	1 / 12 (8.33%)	2 / 12 (16.67%)	2 / 7 (28.57%)
occurrences all number	0	4	0	0	0	0	3	0	1	0	2	2	2	3	2	0	1	1	2	2	2	1	8	6	1	7	4
Hyperuricaemia
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hyperkalaemia
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 8 (12.50%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	1	1	0	0	0	0	0	0	0	0	0	3	0	0
Hypertriglyceridaemia
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	1 / 8 (12.50%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	1 / 25 (4.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	3	0	0	0	0	1	0	0	0	0	1	0	2	0	0	1	0	0
Hypoalbuminaemia
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	1 / 12 (8.33%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 12 (0.00%)	0 / 12 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	6	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1
Hypophagia
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	1 / 14 (7.14%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Gout
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	1 / 10 (10.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	8	0
Hyperamylasaemia
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0
Hypercholesterolaemia
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 12 (8.33%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Type 1 diabetes mellitus1
alternative assessment type: Systematic
subjects affected / exposed	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 12 (0.00%)	0 / 11 (0.00%)	0 / 11 (0.00%)	0 / 10 (0.00%)	0 / 21 (0.00%)	0 / 28 (0.00%)	0 / 29 (0.00%)	0 / 8 (0.00%)	0 / 12 (0.00%)	0 / 21 (0.00%)	0 / 35 (0.00%)	0 / 14 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 6 (0.00%)	0 / 8 (0.00%)	0 / 10 (0.00%)	0 / 25 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

31 Aug 2015

Amendment 1: The following are FDA directed changes to the original Protocol: Table 2 of Schedule of Activities was revised to include 2 additional PK blood samples for PF-05082566 and avelumab on Cycle 1 Day 8 and Cycle 1 Day 15. Protocol Section 1.2.2.3 was revised to include safety data from patients receiving 10 mg/kg of PF-05082566. Protocol Summary, Protocol Sections 3.1.3, Figure 3, Section 9.2 and Table 9, the wording for stopping a dose level cohort based on the number of DLTs in the Phase 1b portion of the study was changed from 3 out of 6 patients to 2 out of 6 patients with DLTs. Protocol Section 3.2, the definition of Grade 3 diarrhea was revised to place a restriction on the time before it is considered a DLT. The definition of DLT for liver function tests was revised to reflect Hy’s Law. Protocol Section 4.1, inclusion criterion 1 was revised so that patients with ALK-rearranged or EGFR-mutated NSCLC have received and are refractory to or intolerant of standard treatment options. Protocol Section 5.3.5.3 was revised to require investigators to re-consent patients who will continue on therapy after initial progression of disease. Table 5 in Protocol Section 5.3.7.2 was revised to remove “single value out of normal range that are likely related to treatment as assessed by the Investigator” under “Exceptions to permanent discontinuation”. In addition, compound number MSB0010718C has been corrected throughout the document, Section 1.2.2 heading was revised to “anti-4-1BB”, and Section 3.1.2 was revised to remove wording not required per protocol template and was redundant with Section 3.1.3.

29 Feb 2016

Amendment 2 TNBC cohort Combo A, Combo B. SOA Combo A; 7.1.4 remove ANA, ANCA, RF tests. SOA Combo A) PE hematology, blood chemistry, vital signs remove Day 8, 22, Cycle 3. SOA Combo A Contraceptive check Day 1 each cycle, EOT, end of contraception. Concomitant treatment collection, . SOA Combo A TCR Analysis. SOA Combo A Footnote 22 updated. SOA Combo A Footnotes 28, 29 biopsies. SOA Combo B Section 1 TNBC/colorectal cancer tumor types and description Combo B added. 1.2.2.3 pre-clinical combo studies move. 1.2.2.4 Clinical Efficacy PF-05082566. 1.2.3 Background PF-04518600. 1.2.4 Rationale Combo B. 1.2.5 Title changed. 1.2.5.3: PF-04518600 doses. 1.3 PF-04518600 to Benefit/Risk Assessment. 1.4 Biomarkers. Section 2 Objectives/endpoints. Section 3 Phase 2 design for Combo A. Phase 1b dose-escalation lead in and Phase 2 for Combo B. MSI status. 3.3 MTD definition. 3.4 MAD definition. Inclusion criterion 1 updated, Inclusion criterion 8 updated. Exclusion criterion 1 revised. Exclusion criterion 10 revised. 4.3 Lifestyle guidelines revised. Section 5 PF-04518600 information. Section 5.1 Allocation to treatment. 5.3.3 Supplies PF-04518600. 5.3.4.3 Formulation/packaging PF-04528600. 5.3.5.3 Preparation PF-04518600. 5.3.6 Premeditations. 5.3.6.1 infusion window. 5.3.6.3 Administration PF-04518600. 6.1.1 Archival/de novo biopsies. 7.2.3 PK analysis PF-04518600. 7.3.3 Immunogenicity assessment PF-04518600. 7.4 biomarker collections/analyses. 7.5.1 Combo B. 7.6 Blood samples, CEA testing. MRI, bone imaging. Section 9 Combo B. 9.1 Analysis sets. 9.2.2 Statistical methods Combo B. 9.3 Sample size. 9.4 Combo B in efficacy analysis. 9.5.1.1 Biomarker endpoints. Section 16 References 22,27, 34-49. Appendix 1 RECIST v1.1 appendix. Appendix 4 irRECIST appendix. Appendix 4 target lesions/lymph nodes measured short axis. Administrative changes.

22 Apr 2016

Amendment 3: Section 3.1.5: Table 8 regarding the decision rules of the mTPI design was revised to reflect a target DLT rate change from 30% to 25% per FDA request. Section 3.3: The definition of MTD for PF-04518600 in combination with avelumab was revised to clarify that MTD decision making is dependent on the higher dose of PF-04518600 tested in combination with 10 mg/kg avelumab. Section 4.1: Inclusion criterion #1 for Combination A Phase 2 was revised to not include patients with PD-1 or PD-L1 refractory disease (best response of PD). Section 9.2.2: The target probability rate was changed from 0.3 to 0.25, and the DLT interval was changed to (0.16, 0.33) per FDA request.

11 Aug 2016

Amendment 4: Section 3.1.5: Wording added to allow flexibility in the timing and the number of patients in dose escalation cohorts.

01 Oct 2016

Amendment 5: PF-05082566 replaced with proposed International Nonproprietary Name, utomilumab. Avelumab and utomilumab clinical experience data (safety, PK, immunogenicity) updated in Introduction. Combination A (avelumab plus utomilumab) cohorts of SCLC patients n=20 and 1st line NSCLC n=20 added to Phase 2. Sample size for TNBC cohort reduced to 20, sample size justifications for tumor-specific cohorts added/modified. Combination B: population modified, Phase 2 tumor-specific cohorts to be evaluated include 25 patients each including at least 20 anti-PD-1/PD-L1 treatment-naïve patients, up to 5 patients who previously received anti-PD-1/PD-L1 therapy. Two new combinations, avelumab plus other cancer immunotherapies added Combination C, avelumab plus PD 0360324 and Combination D, avelumab plus utomilumab plus PF-04518600. Due to addition of these new combinations protocol modified. Protocol Summary updated; SOAs updated; SOA Tables 5–8 added; Section 1 Introduction updated; Background information for combination agent PD 0360324 added; Study rationale for Combinations C and D added. Section 2 Study Objectives and Endpoints specific to Combinations C and D; Section 3 Study Design updated for Combinations C and D. Study Design section revised to minimize redundancies across various combinations; Section 4 Patient Selection updated for Combinations C and D; Section 5, Study Treatments, updated to include investigational product details for PD 0360324, Combination C. Dose modification guidelines for PD 0360324 and considerations specific to Combination D added; Section 7 Assessments updated to include details regarding PK, immunogenicity, and biomarker/ PD sample collections for Combinations C and D; Section 9 Data Analysis/Statistical Methods sample size determinations for Combinations C and D; Appendix 3 Abbreviations and Definition of Terms updated. Changes made to protocol structure to reduce redundancies and other administrative changes made.

16 May 2017

Amendment 6: New combination of avelumab plus PF-06840003 for evaluation in patients with advanced solid tumors, Combination E. Combination E updates: Protocol Summary updated; SOA Tables 9 and 10 added; Section 1, Introduction, updated; Background information for PF-06840003 added; Study rationale. Section 3, Study Design; Section 4, Patient Selection; Section 5, Study Treatments, include PF-06840003; Section 7, Assessments, PK, immunogenicity, ECG, biomarker assessments; Section 9, Data Analysis/Statistical Methods, statistical methods. Following changes made: 2 new cohorts (Cohort A9 and Cohort A10). Modified tumor-type inclusion criteria. Allowed Tenosynovial giant cell tumor/pigmented villonodular synovitis in combination C. Instructions for treatment modifications for drug-related toxicities and management of irAEs updated/ reorganized. Overview of changes: SOA, Tables 1 and 2, Combination A evaluations for Cohorts A9 and A10. Section 1, Introduction, updated; Clinical experience data (safety, PK, immunogenicity, preliminary efficacy) updated for avelumab, PF-04518600, utolimumab; Study rationale for Cohorts A9 and A10 added; Advanced/metastatic CRC removed as a specified tumor type across study. Section 3, Study Design, updated Cohorts A9 and A10. Section 4, Patient Selection, Inclusion Criterion 1 modified. Section 5, Study Treatments, Table 18 (Investigational Product Treatment Modifications for Drug-Related Toxicity) updated, Table 20 (Management of irAEs) modified. Figure 15 (Assessment and Initial Management of Tumor Lysis Syndrome) deleted. Section 6, Study Procedures, tumor biospecimens revised; requirements for assessments during follow-up period revised. Section 7, Assessments, updated PK sampling assessments/tumor biomarkers. Section 8, AE Reporting updated. Section 9, Data Analysis/Statistical Methods, sample size methodology for Combinations A/B updated; PK and ECG analyses added. Minor administrative/editorial changes.

18 Sep 2017

Amendment 7: The primary purpose of Protocol Amendment 7 was to remove a new combination treatment of avelumab plus PF-06840003 for evaluation in patients with advanced solid tumors (Combination E) sections. A high-level summary of changes made to remove the Combination E by section is as follows: Protocol Summary; Schedule of Activities (SOA) updated (Tables 9 and 10 has been removed); Section 1, Introduction, has been updated and all information pertaining to Combination E has been removed including; Background information for the new combination agent (PF-06840003); Study rationale for Combination E. Section 3, Study Design, updated to remove details specific to Combination E; Section 4, Patient Selection, updated to remove details specific to Combination E; Section 5, Study Treatments, updated to remove investigational product details for PF-06840003; Section 7, Assessments, updated to remove details regarding PK, ECG, and biomarker assessments specific to Combination E; Section 9, Data Analysis/Statistical Methods, updated to remove section on statistical methods specific to Combination E. Other minor administrative and/or editorial changes were also incorporated to improve overall document clarity and accuracy.

27 Feb 2019

Amendment 8: New combo treatments for SCCHN: Cohort F1, Cohort F2, Cohort F3. Status of Combos A, B, C and procedures updated. Combo F will only enroll patients in US. Protocol Summary; SOA Tables 3, 5, 7, 9 for Combo A to D to remove onsite Day60 and Day90 follow up visits and safety labs; SOA Tables 6, 8, 10 for Combo B to D to remove biomarker assessments Cycles 7, 13, Day 30 follow up visit; SOA added Combo F Tables 11, 12; Section 1, updated; Background information new combo agent (CMP-001) added; Study rationale Combo F added. Section 2 Primary endpoint updated for Combos A, B, C, D; Primary endpoint Combo F added; Removed exploratory objective/endpoint for irRECIST. Section 3, updated Study Design for Combo F; Frequency of tumor assessments updated; Status of combo A, B, C updated. Patient Selection criteria for Combo F; Updated lifestyle/contraceptive guidance. Section 5, added details for CMP-001, edited management of infusion-related reactions; added management of cytokine release syndrome and injection site reactions; Updated premedication/observation period-for avelumab. Section 6, on-treatment biopsy for Combo F; maximum duration of study treatment; Updated follow-up visit procedures/lab tests. Section 7, updated for PK, immunogenicity, ECG, biomarker assessments for Combo F; Requirement to collect and store images by an independent third-party lab removed; Section 9, updated statistical methods specific to Combo F; Appendix 3 updated; Appendix 4, Immune Related Response Criteria removed and added text to clarify CMP-001 study drug administration. PACLs updates Clarify banked biospecimens optional exploratory research; Section 7.4, updated handling of biospecimens; Section 7.5.1, added text for obtained blood samples for pharmacogenomics/biomarker analyses. SOA tables 3, 5, 7, 9 to modify assessments for patients. Other minor changes. Change for PDAL Section 7.1.4, requirement to review lab test results prior to study drug.

13 Dec 2019

Amendment 9: Modified inclusion criteria for Combo F and updated the status of Combo D. SOA updated for Combo F Tables 11 and 12, Patient Selection: Modified inclusion criterion for prior immunotherapy Combo F; Modified inclusion criterion eligibility for intralesional administration in Combo F; Modified exclusion criterion for prior radiotherapy. Addition of Section 5.3.3.2.5 detailing CMP-001 diluent; Updated Timing of Investigational Product Administration to allow investigational product administration to be spread over two consecutive days for Combo F; Premedication guidance for Combo F updated for dosing spread over 2 days; Stress dose steroids prophylaxis for patients who have experienced CRS updated to align with dose modification requirement to discontinue study treatment for CRS of Grade 3 lasting >24 hours and CRS ≥Grade 4. Appendix 4, CMP-administration: Details on tumor lesion selection criteria for injectable lesions added. Minor administrative and/or editorial changes. PACL changes: SOA, Combo A, B, C, D Footnote(s) 15 & Combo F Footnote 14 and Section 7.1.6 to clarify single ECG requirement at End of Treatment(EOT); SOA updated Combo D Footnote 16 & Combo F Footnote 15 to clarify hepatitis B blood tests requirements; SOA Combo F Footnote 1 updated to clarify screening period; Sections 5.3.2 Other Immune Modulators and Section 5.3.3 Formulation Dosage/Forms and Packaging updated to add CMP-001 diluent; Section 5.3.5.2 Combo F observation period updated to correct typo error; Section 13 Definition of End of Trial duplicate paragraph deleted. Protocol Summary and Section 3, Study Design to document current status of Combo D. SOA updated Tables 6, 8, and 10, Combo B to D to remove the requirement of immune cell phenotyping at EOT/Withdrawal Visit; SOA Tables 5 and 9, Combo B and D to clarify PF-04518600 administration on Day 15 of Cycles ≥24; SOA table formatting corrected Tables 3, 5, 7, 9 and 11 to show Cycles ≥24 visits in On Treatment column

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

Level of clinical activity observed in Cohorts C11 to C13 and D11 to D32 did not support development beyond Phase 1b. For combination F, level of clinical activity did not warrant further enrolment. Therefore, Phase 2 not planned.

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Clinical trials

Clinical Trial Results: A PHASE 1B/2 OPEN-LABEL STUDY TO EVALUATE SAFETY, CLINICAL ACTIVITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB (MSB0010718C) IN COMBINATION WITH OTHER CANCER IMMUNOTHERAPIES IN PATIENTS WITH ADVANCED MALIGNANCIES

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Phase 1b Lead-in: Number of Subjects With First 2 Cycles Dose Limiting Toxicity (DLT) for Combination A

Primary: Phase 1b Lead-in: Number of Subjects With First 2 Cycles Dose Limiting Toxicity (DLT) for Combination A

Primary: Phase 1b Lead-in: Number of Subjects With First 2 Cycles DLT for Combination D

Primary: Phase 1b Lead-in: Number of Subjects With First 2 Cycles DLT for Combination D

Primary: Phase 1b Lead-in: Number of Subjects With First 2 Cycles DLT for Combination C

Primary: Phase 1b Lead-in: Number of Subjects With First 2 Cycles DLT for Combination C

Primary: Phase 1b Lead-in: Number of Subjects With First 2 Cycles DLT for Combination B

Primary: Phase 1b Lead-in: Number of Subjects With First 2 Cycles DLT for Combination B

Primary: Phase 2: Percentage of Subjects With Confirmed OR as per RECIST v 1.1 by Investigator Assessment for Combination B

Primary: Phase 2: Percentage of Subjects With Confirmed OR as per RECIST v 1.1 by Investigator Assessment for Combination B

Primary: Phase 2: Percentage of Subjects With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment for Combination A

Primary: Phase 2: Percentage of Subjects With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment for Combination A

Primary: Phase 1b Lead-in: Number of Subjects With First Cycle DLT for Combination F

Primary: Phase 1b Lead-in: Number of Subjects With First Cycle DLT for Combination F

Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination A

Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination A

Secondary: Number of Subjects With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination B

Secondary: Number of Subjects With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination B

Secondary: Number of Subjects With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination C

Secondary: Number of Subjects With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination C

Secondary: Number of Subjects With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination D

Secondary: Number of Subjects With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination D

Secondary: Number of Subjects With New Abnormal or Worsening Hematology Laboratory Test by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3: Combination A

Secondary: Number of Subjects With New Abnormal or Worsening Hematology Laboratory Test by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3: Combination A

Secondary: Number of Subjects With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination F

Secondary: Number of Subjects With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination F

Secondary: Number of Subjects With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination B

Secondary: Number of Subjects With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination B

Secondary: Number of Subjects With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination C

Secondary: Number of Subjects With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination C

Secondary: Number of Subjects With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination D

Secondary: Number of Subjects With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination D

Secondary: Number of Subjects With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination F

Secondary: Number of Subjects With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination F

Secondary: Number of Subjects With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination A

Secondary: Number of Subjects With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination A

Secondary: Number of Subjects With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination B

Secondary: Number of Subjects With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination B

Secondary: Number of Subjects With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination C

Secondary: Number of Subjects With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination C

Secondary: Number of Subjects With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination D

Secondary: Number of Subjects With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination D

Secondary: Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination A

Secondary: Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination A

Secondary: Number of Subjects With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination F

Secondary: Number of Subjects With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination F

Secondary: Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination A

Secondary: Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination A

Secondary: Maximum Observed Plasma Concentration (Cmax) of Avelumab and PF-04518600 in Combination B

Secondary: Maximum Observed Plasma Concentration (Cmax) of Avelumab and PF-04518600 in Combination B

Secondary: Maximum Observed Plasma Concentration (Cmax) of Avelumab and PD 0360324 in Combination C

Secondary: Maximum Observed Plasma Concentration (Cmax) of Avelumab and PD 0360324 in Combination C

Secondary: Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination D

Secondary: Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination D

Secondary: Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination D

Secondary: Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination D

Secondary: Maximum Observed Plasma Concentration (Cmax) of PF-04518600 in Combination D

Secondary: Maximum Observed Plasma Concentration (Cmax) of PF-04518600 in Combination D

Secondary: Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination F

Secondary: Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination F

Secondary: Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination A

Secondary: Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination A

Secondary: Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination A

Secondary: Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination A

Secondary: Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PF-04518600 in Combination B

Secondary: Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PF-04518600 in Combination B

Secondary: Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PD 0360324 in Combination C

Secondary: Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PD 0360324 in Combination C

Secondary: Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination D

Secondary: Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination D

Clinical Trial Results:
A PHASE 1B/2 OPEN-LABEL STUDY TO EVALUATE SAFETY, CLINICAL ACTIVITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB (MSB0010718C) IN COMBINATION WITH OTHER CANCER IMMUNOTHERAPIES IN PATIENTS WITH ADVANCED MALIGNANCIES