Download PDF

Clinical Trial Results:
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies (FIGHT-101)

Summary
EudraCT number	2016-002831-14
Trial protocol	DK
Global end of trial date	17 Dec 2021

Results information
Results version number	v2(current)
This version publication date	26 Jan 2023
First version publication date	15 Dec 2022
Other versions	v1
Version creation reason	Correction of full data set Revisions made to align with changes made to ClinicalTrials.gov results summary.

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

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

INCB 54828-101

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Incyte Corporation

Sponsor organisation address

1801 Augustine Cutoff Drive, Wilmington, United States, 19803

Public contact

Study Director, Incyte Corporation, 1 8554633463, medinfo@incyte.com

Scientific contact

Study Director, Incyte Corporation, 1 8554633463, medinfo@incyte.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

17 Dec 2021

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

17 Dec 2021

Was the trial ended prematurely?

Main objective of the trial

The purpose of this study was to evaluate the safety, tolerability, and pharmacological activity of pemigatinib in participants with advanced malignancies. This study was conducted in three parts: dose escalation (Part 1), dose expansion (Part 2), and combination therapy (Part 3).

Protection of trial subjects

This study was to be performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and conducted in adherence to the study Protocol, Good Clinical Practices as defined in Title 21 of the United States Code of Federal Regulations Parts 50, 54 56, 312, and Part 11 as well as International Council for Harmonisation Good Clinical Practice (ICH GCP) consolidated guidelines (E6) and applicable regulatory requirements.

Background therapy

Evidence for comparator

Actual start date of recruitment

27 Feb 2015

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 199

Country: Number of subjects enrolled

Denmark: 2

Worldwide total number of subjects

201

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)

127

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Screening details

This study was conducted at 15 sites: 14 in the United States; 1 in Denmark. The study was conducted in 3 parts. Participants self-administered once daily doses of pemigatinib on a 2-weeks-on/1-week-off therapy (intermittent) or continuous schedule. Participants also self-administered twice daily doses of pemigatinib on a continuous schedule.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Part 1: Intermittent pemigatinib 1/2/4 mg QD

Arm description

Participants self-administered oral pemigatinib 1/2/4 milligrams (mg) once daily (QD) on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Part 1: Intermittent pemigatinib 6 mg QD

Arm description

Participants self-administered oral pemigatinib 6 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Part 1: Intermittent pemigatinib 9 mg QD

Arm description

Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Part 1: Intermittent pemigatinib 13.5 mg QD

Arm description

Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Part 1: Intermittent pemigatinib 20 mg QD

Arm description

Participants self-administered oral pemigatinib 20 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Part 1: Continuous pemigatinib 9 mg QD

Arm description

Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Part 1: Continuous pemigatinib 13.5 mg QD

Arm description

Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Part 1: Continuous pemigatinib 20 mg QD

Arm description

Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Part 1: Continuous pemigatinib 7.5 mg BID

Arm description

Participants self-administered oral pemigatinib 7.5 mg twice daily (BID) on Days 1 through 21 of each 21-day cycle.

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Part 1: Continuous pemigatinib 10 mg BID

Arm description

Participants self-administered oral pemigatinib 10 mg BID on Days 1 through 21 of each 21-day cycle.

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Part 2: Intermittent pemigatinib 9 mg QD

Arm description

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Part 2: Intermittent pemigatinib 13.5 mg QD

Arm description

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Part 2: Continuous pemigatinib 9 mg QD

Arm description

Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Part 2: Continuous pemigatinib 13.5 mg QD

Arm description

Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Part 2: Continuous pemigatinib 20 mg QD

Arm description

Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Part 3: Gem/Cis/intermittent pemigatinib 9 mg

Arm description

Participants received gemcitabine (Gem) intravenously starting at 1000 mg/meters squared (m^2) on Days 1 and 8 of each 21-day cycle. Cisplatin (Cis) was administered intravenously starting at 70 mg/m^2 once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin.

Arm type

Experimental

Investigational medicinal product name

gemcitabine

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

1000 mg/m^2 on Days 1 and 8 of each 21-day cycle

Investigational medicinal product name

cisplatin

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

70 mg/m^2 once every 3 weeks on Day 1 of each 21-day cycle

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg

Arm description

Participants received gemcitabine intravenously starting at 1000 mg/m^2 on Days 1 and 8 of each 21-day cycle. Cisplatin was administered intravenously starting at 70 mg/m^2 once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin.

Arm type

Experimental

Investigational medicinal product name

gemcitabine

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

1000 mg/m^2 on Days 1 and 8 of each 21-day cycle

Investigational medicinal product name

cisplatin

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

70 mg/m^2 once every 3 weeks on Day 1 of each 21-day cycle

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Part 3: Tras/intermittent pemigatinib 13.5 mg

Arm description

Trastuzumab (Tras) was administered as an open-label, commercial product at an initial intravenous dose of 8 mg/kilograms (kg), followed by 6 mg/kg intravenously once every 3 weeks. The dose could have been adjusted for toxicity management, per commercial labeling. The investigator could have interrupted, modified, or discontinued trastuzumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of trastuzumab.

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Investigational medicinal product name

trastuzumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

8 mg/kg initial dose followed by 6 mg/kg Q3W

Part 3: Doc/intermittent pemigatinib 13.5 mg

Arm description

Participants received docetaxel (Doc) intravenously starting at 75 mg/m^2 once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of docetaxel.

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Investigational medicinal product name

docetaxel

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

75 mg/m^2 Q3W

Part 3: Pem/intermittent pemigatinib 9 mg

Arm description

Participants received pembrolizumab (Pem) intravenously at 200 mg once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Investigational medicinal product name

pembrolizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

200 mg Q3W

Part 3: Pem/intermittent pemigatinib 13.5 mg

Arm description

Participants received pembrolizumab intravenously at 200 mg once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.

Arm type

Experimental

Investigational medicinal product name

pembrolizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

200 mg Q3W

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Part 3: Pem/continuous pemigatinib 13.5 mg

Arm description

Participants received pembrolizumab intravenously at 200 mg once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Investigational medicinal product name

pembrolizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

200 mg Q3W

Part 3: Ref/continuous pemigatinib 9 mg

Arm description

Retifanlimab (Ref) was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial intravenous dose of 500 mg. Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Investigational medicinal product name

retifanlimab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

500 mg Q4W on a 28-day cycle

Part 3: Ref/continuous pemigatinib 13.5 mg

Arm description

Retifanlimab was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial intravenous dose of 500 mg. Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Investigational medicinal product name

retifanlimab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

500 mg Q4W on a 28-day cycle

Part 3: Ref/continuous pemigatinib 20 mg

Arm description

Retifanlimab was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial intravenous dose of 500 mg. Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.

Arm type

Experimental

Investigational medicinal product name

pemigatinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

QD or BID intermittent or continuous dosing

Investigational medicinal product name

retifanlimab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

500 mg Q4W on a 28-day cycle

Number of subjects in period 1	Part 1: Intermittent pemigatinib 1/2/4 mg QD	Part 1: Intermittent pemigatinib 6 mg QD	Part 1: Intermittent pemigatinib 9 mg QD	Part 1: Intermittent pemigatinib 13.5 mg QD	Part 1: Intermittent pemigatinib 20 mg QD	Part 1: Continuous pemigatinib 9 mg QD	Part 1: Continuous pemigatinib 13.5 mg QD	Part 1: Continuous pemigatinib 20 mg QD	Part 1: Continuous pemigatinib 7.5 mg BID	Part 1: Continuous pemigatinib 10 mg BID	Part 2: Intermittent pemigatinib 9 mg QD	Part 2: Intermittent pemigatinib 13.5 mg QD	Part 2: Continuous pemigatinib 9 mg QD	Part 2: Continuous pemigatinib 13.5 mg QD	Part 2: Continuous pemigatinib 20 mg QD	Part 3: Gem/Cis/intermittent pemigatinib 9 mg	Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg	Part 3: Tras/intermittent pemigatinib 13.5 mg	Part 3: Doc/intermittent pemigatinib 13.5 mg	Part 3: Pem/intermittent pemigatinib 9 mg	Part 3: Pem/intermittent pemigatinib 13.5 mg	Part 3: Pem/continuous pemigatinib 13.5 mg	Part 3: Ref/continuous pemigatinib 9 mg	Part 3: Ref/continuous pemigatinib 13.5 mg	Part 3: Ref/continuous pemigatinib 20 mg
Started	3	4	3	6	6	9	10	9	4	3	4	44	5	20	6	1	7	6	7	3	14	9	7	9	2
Completed	0	0	0	0	0	0	1	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	1
Not completed	3	4	3	6	6	9	9	8	4	3	4	44	5	20	5	1	7	6	7	3	14	9	7	8	1
Adverse event, serious fatal	2	2	3	6	6	6	5	8	4	2	3	29	4	15	2	1	7	5	5	3	7	5	6	3	-
Placed on Hospice; Declined Further Follow-up	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	1	-
Consent withdrawn by subject	-	1	-	-	-	1	1	-	-	-	-	13	1	2	3	-	-	-	1	-	2	1	-	1	-
Clinical Decline; Withdrew by Physician	-	-	-	-	-	-	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
Adverse event, non-fatal	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	1	-
Rolled Over to Another Protocol	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	1	-	-	-	-
Study Terminated by Sponsor	-	-	-	-	-	2	2	-	-	1	-	1	-	3	-	-	-	1	1	-	1	1	1	2	1
Lost to follow-up	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	1	1	-	-	-
Disease Progression	-	1	-	-	-	-	-	-	-	-	1	1	-	-	-	-	-	-	-	-	2	1	-	-	-

Baseline characteristics

Top of page

Reporting group title

Part 1: Intermittent pemigatinib 1/2/4 mg QD

Reporting group description

Reporting group title

Part 1: Intermittent pemigatinib 6 mg QD

Reporting group description

Reporting group title

Part 1: Intermittent pemigatinib 9 mg QD

Reporting group description

Reporting group title

Part 1: Intermittent pemigatinib 13.5 mg QD

Reporting group description

Reporting group title

Part 1: Intermittent pemigatinib 20 mg QD

Reporting group description

Reporting group title

Part 1: Continuous pemigatinib 9 mg QD

Reporting group description

Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.

Reporting group title

Part 1: Continuous pemigatinib 13.5 mg QD

Reporting group description

Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.

Reporting group title

Part 1: Continuous pemigatinib 20 mg QD

Reporting group description

Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.

Reporting group title

Part 1: Continuous pemigatinib 7.5 mg BID

Reporting group description

Participants self-administered oral pemigatinib 7.5 mg twice daily (BID) on Days 1 through 21 of each 21-day cycle.

Reporting group title

Part 1: Continuous pemigatinib 10 mg BID

Reporting group description

Participants self-administered oral pemigatinib 10 mg BID on Days 1 through 21 of each 21-day cycle.

Reporting group title

Part 2: Intermittent pemigatinib 9 mg QD

Reporting group description

Reporting group title

Part 2: Intermittent pemigatinib 13.5 mg QD

Reporting group description

Reporting group title

Part 2: Continuous pemigatinib 9 mg QD

Reporting group description

Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.

Reporting group title

Part 2: Continuous pemigatinib 13.5 mg QD

Reporting group description

Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.

Reporting group title

Part 2: Continuous pemigatinib 20 mg QD

Reporting group description

Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.

Reporting group title

Part 3: Gem/Cis/intermittent pemigatinib 9 mg

Reporting group description

Reporting group title

Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg

Reporting group description

Reporting group title

Part 3: Tras/intermittent pemigatinib 13.5 mg

Reporting group description

Reporting group title

Part 3: Doc/intermittent pemigatinib 13.5 mg

Reporting group description

Reporting group title

Part 3: Pem/intermittent pemigatinib 9 mg

Reporting group description

Reporting group title

Part 3: Pem/intermittent pemigatinib 13.5 mg

Reporting group description

Reporting group title

Part 3: Pem/continuous pemigatinib 13.5 mg

Reporting group description

Participants received pembrolizumab intravenously at 200 mg once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.

Reporting group title

Part 3: Ref/continuous pemigatinib 9 mg

Reporting group description

Reporting group title

Part 3: Ref/continuous pemigatinib 13.5 mg

Reporting group description

Reporting group title

Part 3: Ref/continuous pemigatinib 20 mg

Reporting group description

Retifanlimab was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial intravenous dose of 500 mg. Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.

Reporting group values	Part 1: Intermittent pemigatinib 1/2/4 mg QD	Part 1: Intermittent pemigatinib 6 mg QD	Part 1: Intermittent pemigatinib 9 mg QD	Part 1: Intermittent pemigatinib 13.5 mg QD	Part 1: Intermittent pemigatinib 20 mg QD	Part 1: Continuous pemigatinib 9 mg QD	Part 1: Continuous pemigatinib 13.5 mg QD	Part 1: Continuous pemigatinib 20 mg QD	Part 1: Continuous pemigatinib 7.5 mg BID	Part 1: Continuous pemigatinib 10 mg BID	Part 2: Intermittent pemigatinib 9 mg QD	Part 2: Intermittent pemigatinib 13.5 mg QD	Part 2: Continuous pemigatinib 9 mg QD	Part 2: Continuous pemigatinib 13.5 mg QD	Part 2: Continuous pemigatinib 20 mg QD	Part 3: Gem/Cis/intermittent pemigatinib 9 mg	Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg	Part 3: Tras/intermittent pemigatinib 13.5 mg	Part 3: Doc/intermittent pemigatinib 13.5 mg	Part 3: Pem/intermittent pemigatinib 9 mg	Part 3: Pem/intermittent pemigatinib 13.5 mg	Part 3: Pem/continuous pemigatinib 13.5 mg	Part 3: Ref/continuous pemigatinib 9 mg	Part 3: Ref/continuous pemigatinib 13.5 mg	Part 3: Ref/continuous pemigatinib 20 mg	Total
Number of subjects	3	4	3	6	6	9	10	9	4	3	4	44	5	20	6	1	7	6	7	3	14	9	7	9	2	201
Age categorical
Units: Subjects
Adults (18-64 years)	2	4	3	4	5	5	6	6	1	2	4	30	2	12	4	1	7	5	5	2	5	5	2	4	1	127
From 65-84 years	1	0	0	2	1	4	4	3	3	0	0	14	3	8	2	0	0	1	2	1	9	4	5	5	1	73
85 years and over	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	1
Age Continuous
9999=The standard deviation was not calculated for a single participant.
Units: years
arithmetic mean (standard deviation)	60.7 ( 11.24 )	45.5 ( 17.31 )	56.3 ( 4.93 )	59.0 ( 14.79 )	56.2 ( 11.89 )	57.9 ( 15.70 )	61.2 ( 16.88 )	56.3 ( 15.19 )	66.8 ( 4.57 )	68.7 ( 15.89 )	50.3 ( 12.39 )	57.7 ( 11.81 )	63.8 ( 10.69 )	57.4 ( 13.78 )	58.3 ( 8.80 )	61.0 ( 9999 )	54.1 ( 10.43 )	47.8 ( 14.44 )	62.4 ( 9.16 )	55.0 ( 15.72 )	64.7 ( 10.50 )	61.8 ( 10.89 )	63.4 ( 11.43 )	66.9 ( 8.80 )	68.0 ( 7.07 )	-
Sex: Female, Male
Units: participants
Female	2	2	2	3	3	6	5	6	0	2	3	27	5	10	5	0	3	4	3	1	5	3	7	5	1	113
Male	1	2	1	3	3	3	5	3	4	1	1	17	0	10	1	1	4	2	4	2	9	6	0	4	1	88
Race/Ethnicity, Customized
Units: Subjects
White/Caucasian	3	4	2	6	5	8	10	8	4	3	3	37	5	18	6	1	5	6	6	2	10	9	7	9	1	178
Black/African-American	0	0	1	0	1	0	0	0	0	0	0	7	0	0	0	0	1	0	1	1	2	0	0	0	1	15
Asian	0	0	0	0	0	1	0	1	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	4
American-Indian/Alaska Native	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
Native Hawaiian/Pacific Islander	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
Captured as Other	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	2	0	0	0	0	4
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	0	0	0	0	2	1	1	0	0	0	1	4	0	4	0	0	0	0	0	0	1	1	0	0	0	15
Not Hispanic or Latino	2	3	3	6	4	8	9	9	4	3	3	39	5	16	6	1	7	6	7	3	13	8	7	9	1	182
Unknown or Not Reported	1	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	4

End points

Top of page

Reporting group title

Part 1: Intermittent pemigatinib 1/2/4 mg QD

Reporting group description

Reporting group title

Part 1: Intermittent pemigatinib 6 mg QD

Reporting group description

Reporting group title

Part 1: Intermittent pemigatinib 9 mg QD

Reporting group description

Reporting group title

Part 1: Intermittent pemigatinib 13.5 mg QD

Reporting group description

Reporting group title

Part 1: Intermittent pemigatinib 20 mg QD

Reporting group description

Reporting group title

Part 1: Continuous pemigatinib 9 mg QD

Reporting group description

Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.

Reporting group title

Part 1: Continuous pemigatinib 13.5 mg QD

Reporting group description

Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.

Reporting group title

Part 1: Continuous pemigatinib 20 mg QD

Reporting group description

Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.

Reporting group title

Part 1: Continuous pemigatinib 7.5 mg BID

Reporting group description

Participants self-administered oral pemigatinib 7.5 mg twice daily (BID) on Days 1 through 21 of each 21-day cycle.

Reporting group title

Part 1: Continuous pemigatinib 10 mg BID

Reporting group description

Participants self-administered oral pemigatinib 10 mg BID on Days 1 through 21 of each 21-day cycle.

Reporting group title

Part 2: Intermittent pemigatinib 9 mg QD

Reporting group description

Reporting group title

Part 2: Intermittent pemigatinib 13.5 mg QD

Reporting group description

Reporting group title

Part 2: Continuous pemigatinib 9 mg QD

Reporting group description

Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.

Reporting group title

Part 2: Continuous pemigatinib 13.5 mg QD

Reporting group description

Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.

Reporting group title

Part 2: Continuous pemigatinib 20 mg QD

Reporting group description

Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.

Reporting group title

Part 3: Gem/Cis/intermittent pemigatinib 9 mg

Reporting group description

Reporting group title

Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg

Reporting group description

Reporting group title

Part 3: Tras/intermittent pemigatinib 13.5 mg

Reporting group description

Reporting group title

Part 3: Doc/intermittent pemigatinib 13.5 mg

Reporting group description

Reporting group title

Part 3: Pem/intermittent pemigatinib 9 mg

Reporting group description

Reporting group title

Part 3: Pem/intermittent pemigatinib 13.5 mg

Reporting group description

Reporting group title

Part 3: Pem/continuous pemigatinib 13.5 mg

Reporting group description

Participants received pembrolizumab intravenously at 200 mg once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.

Reporting group title

Part 3: Ref/continuous pemigatinib 9 mg

Reporting group description

Reporting group title

Part 3: Ref/continuous pemigatinib 13.5 mg

Reporting group description

Reporting group title

Part 3: Ref/continuous pemigatinib 20 mg

Reporting group description

Retifanlimab was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial intravenous dose of 500 mg. Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.

Subject analysis set title

Parts 1 and 2: Intermittent pemigatinib 9 mg QD

Subject analysis set type

Safety analysis

Subject analysis set description

Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in either Part 1 or Part 2. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Subject analysis set title

Parts 1 and 2: Intermittent pemigatinib 13.5 mg QD

Subject analysis set type

Safety analysis

Subject analysis set description

Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in either Part 1 or Part 2. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Subject analysis set title

Parts 1 and 2: Continuous pemigatinib 9 mg QD

Subject analysis set type

Safety analysis

Subject analysis set description

Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.

Subject analysis set title

Parts 1 and 2: Continuous pemigatinib 13.5 mg QD

Subject analysis set type

Safety analysis

Subject analysis set description

Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.

Subject analysis set title

Parts 1 and 2: Continuous pemigatinib 20 mg QD

Subject analysis set type

Safety analysis

Subject analysis set description

Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.

Subject analysis set title

Parts 1 and 2: intermittent or continuous pemigatinib

Subject analysis set type

Full analysis

Subject analysis set description

Participant self-administered intermittent pemigatinib once daily (QD) or continuous pemigatinib QD or twice daily (BID). Intermittent dosing: participants self-administered oral pemigatinib 1/2/4 milligrams (mg), 6 mg, 9 mg, 13.5 mg, or 20 mg once daily (QD) on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1 or Part 2. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. Continuous dosing: participants self-administered oral pemigatinib 9 mg, 13.5 mg, or 20 mg QD on Days 1 through 21 of each 21-day cycle in Part 1 or Part 2. Participants self-administered oral pemigatinib 7.5 mg or 10 mg BID on Days 1 through 21 of each 21-day cycle in Part 1.

Subject analysis set title

Part 1: Intermittent pemigatinib 1 mg QD

Subject analysis set type

Full analysis

Subject analysis set description

Participants self-administered oral pemigatinib 1 milligram (mg) once daily (QD) on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Subject analysis set title

Part 1: Intermittent pemigatinib 2 mg QD

Subject analysis set type

Full analysis

Subject analysis set description

Participants self-administered oral pemigatinib 2 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Subject analysis set title

Part 1: Intermittent pemigatinib 4 mg QD

Subject analysis set type

Full analysis

Subject analysis set description

Participants self-administered oral pemigatinib 4 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Subject analysis set title

Parts 1 and 2: Intermittent/continuous pemigatinib 9 mg QD

Subject analysis set type

Full analysis

Subject analysis set description

Participants self-administered intermittent or continuous oral pemigatinib 9 mg QD in either Part 1 or Part 2. Intermittent dosing: participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in either Part 1 or Part 2. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. Continuous dosing: participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.

Subject analysis set title

Parts 1 and 2: Intermittent/continuous pemigatinib 13.5 mg QD

Subject analysis set type

Full analysis

Subject analysis set description

Participants self-administered intermittent or continuous oral pemigatinib 13.5 mg QD in either Part 1 or Part 2. Intermittent dosing: participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in either Part 1 or Part 2. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. Continuous dosing: participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.

Subject analysis set title

Parts 1 and 2: Intermittent/continuous pemigatinib 20 mg QD

Subject analysis set type

Full analysis

Subject analysis set description

Participants self-administered intermittent or continuous oral pemigatinib 20 mg QD in either Part 1 or Part 2. Intermittent dosing: participants self-administered oral pemigatinib 20 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. Continuous dosing: participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.

Subject analysis set title

Parts 1 and 2: Intermittent/continuous pemigatinib 9 mg QD

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Parts 1 and 2: Intermittent/continuous pemigatinib 13.5 mg QD

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Parts 1 and 2: Intermittent/continuous pemigatinib 20 mg QD

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fasted

Subject analysis set type

Full analysis

Subject analysis set description

Participants self-administered intermittent or continuous pemigatinib 13.5 mg QD in the fasted state in Part 2. Intermittent dosing: participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. Continuous dosing: participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.

Subject analysis set title

Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fed

Subject analysis set type

Full analysis

Subject analysis set description

Participants self-administered intermittent or continuous pemigatinib 13.5 mg QD in the fed state in Part 2. Intermittent dosing: participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. Continuous dosing: participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.

Subject analysis set title

Part 3: Pem/intermittent pemigatinib 13.5 mg

Subject analysis set type

Full analysis

Subject analysis set description

Primary: Parts 1 and 2 Combined: Number of participants with any treatment-emergent adverse event (TEAE)

Top of page

End point title

Parts 1 and 2 Combined: Number of participants with any treatment-emergent adverse event (TEAE) ^[1] ^[2]

End point description

Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug.

End point type

Primary

End point timeframe

up to 763 days

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: Statistical analysis was not conducted.
[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: Statistical analysis was not conducted.

End point values	Part 1: Intermittent pemigatinib 1/2/4 mg QD	Part 1: Intermittent pemigatinib 6 mg QD	Part 1: Intermittent pemigatinib 20 mg QD	Part 1: Continuous pemigatinib 7.5 mg BID	Part 1: Continuous pemigatinib 10 mg BID	Parts 1 and 2: Intermittent pemigatinib 9 mg QD	Parts 1 and 2: Intermittent pemigatinib 13.5 mg QD	Parts 1 and 2: Continuous pemigatinib 9 mg QD	Parts 1 and 2: Continuous pemigatinib 13.5 mg QD	Parts 1 and 2: Continuous pemigatinib 20 mg QD
Number of subjects analysed	3	4	6	4	3	7	50	14	30	15
Units: participants	3	3	6	4	3	7	50	14	30	15

No statistical analyses for this end point

Primary: Part 3: Number of participants with any TEAE

Top of page

End point title

Part 3: Number of participants with any TEAE ^[3] ^[4]

End point description

End point type

Primary

End point timeframe

up to 869 days

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: Statistical analysis was not conducted.
[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: Statistical analysis was not conducted.

End point values	Part 3: Gem/Cis/intermittent pemigatinib 9 mg	Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg	Part 3: Tras/intermittent pemigatinib 13.5 mg	Part 3: Doc/intermittent pemigatinib 13.5 mg	Part 3: Pem/intermittent pemigatinib 9 mg	Part 3: Pem/intermittent pemigatinib 13.5 mg	Part 3: Pem/continuous pemigatinib 13.5 mg	Part 3: Ref/continuous pemigatinib 9 mg	Part 3: Ref/continuous pemigatinib 13.5 mg	Part 3: Ref/continuous pemigatinib 20 mg
Number of subjects analysed	1	7	6	7	3	14	9	7	9	2
Units: participants	1	7	6	7	3	14	9	7	9	2

No statistical analyses for this end point

Primary: E0 following once daily dosing of pemigatinib as monotherapy in Parts 1 and 2

Top of page

End point title

E0 following once daily dosing of pemigatinib as monotherapy in Parts 1 and 2 ^[5]

End point description

E0 was defined as the Baseline serum concentration of phosphate. The average serum concentration of phosphate on Cycle 1 Days 8 and 15 was chosen as a dependent variable for E-R analysis, which was independent of the intermittent dosing and continuous dosing regimens. Therefore, the intermittent dosing and continuous dosing groups from Parts 1 and 2 were combined into a single analysis group for E-R analysis.

End point type

Primary

End point timeframe

predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles

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: Statistical analysis was not conducted.

End point values	Parts 1 and 2: intermittent or continuous pemigatinib
Number of subjects analysed	93
Units: milligrams per deciliter (mg/dL)
geometric mean (geometric coefficient of variation)	3.66 ( 1.91 )

No statistical analyses for this end point

Primary: EC50 following once daily dosing of pemigatinib as monotherapy in Parts 1 and 2

Top of page

End point title

EC50 following once daily dosing of pemigatinib as monotherapy in Parts 1 and 2 ^[6]

End point description

EC50 was defined as the pemigatinib steady-state area under the plasma or serum concentration-time curve that increases 50% of serum phosphate. The average serum concentration of phosphate on Cycle 1 Days 8 and 15 was chosen as a dependent variable for E-R analysis, which was independent of the intermittent dosing and continuous dosing regimens. Therefore, the intermittent dosing and continuous dosing groups from Parts 1 and 2 were combined into a single analysis group for E-R analysis.

End point type

Primary

End point timeframe

predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles

Notes
[6] - 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: Statistical analysis was not conducted.

End point values	Parts 1 and 2: intermittent or continuous pemigatinib
Number of subjects analysed	93
Units: hours*nanomoles
geometric mean (geometric coefficient of variation)	1573 ( 21.6 )

No statistical analyses for this end point

Primary: Emax following once daily dosing of pemigatinib as monotherapy in Parts 1 and 2

Top of page

End point title

Emax following once daily dosing of pemigatinib as monotherapy in Parts 1 and 2 ^[7]

End point description

Emax was defined as the maximum degree of increasing of serum phosphate by pemigatinib. The average serum concentration of phosphate on Cycle 1 Days 8 and 15 was chosen as a dependent variable for E-R analysis, which was independent of the intermittent dosing and continuous dosing regimens. Therefore, the intermittent dosing and continuous dosing groups from Parts 1 and 2 were combined into a single analysis group for E-R analysis.

End point type

Primary

End point timeframe

predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles

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: Statistical analysis was not conducted.

End point values	Parts 1 and 2: intermittent or continuous pemigatinib
Number of subjects analysed	93
Units: mg/dL
geometric mean (geometric coefficient of variation)	5.76 ( 7.76 )

No statistical analyses for this end point

Primary: Highest serum phosphate concentration following pemigatinib as monotherapy in Parts 1 and 2

Top of page

End point title

Highest serum phosphate concentration following pemigatinib as monotherapy in Parts 1 and 2 ^[8]

End point description

Serum phosphate concentration was assessed throughout Parts 1 and 2. The average serum concentration of phosphate on Cycle 1 Days 8 and 15 was chosen as a dependent variable for E-R analysis, which was independent of the intermittent dosing and continuous dosing regimens. Therefore, the intermittent dosing and continuous dosing groups from Parts 1 and 2 were combined into a single analysis group for E-R analysis.

End point type

Primary

End point timeframe

predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles

Notes
[8] - 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: Statistical analysis was not conducted.

End point values	Parts 1 and 2: intermittent or continuous pemigatinib
Number of subjects analysed	93
Units: mg/dL
number (not applicable)
Minimum value in range of highest values	3.5
Maximum value in range of highest values	11.2

No statistical analyses for this end point

Secondary: Part 2: Overall response rate (ORR)

Top of page

End point title

Part 2: Overall response rate (ORR) ^[9]

End point description

ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as determined by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

End point type

Secondary

End point timeframe

up to 126 days

Notes
[9] - 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: Statistical analysis was not conducted.

End point values	Part 2: Intermittent pemigatinib 9 mg QD	Part 2: Intermittent pemigatinib 13.5 mg QD	Part 2: Continuous pemigatinib 9 mg QD	Part 2: Continuous pemigatinib 13.5 mg QD	Part 2: Continuous pemigatinib 20 mg QD
Number of subjects analysed	4	44	5	20	6
Units: percentage of participants
number (confidence interval 95%)	25.0 (0.6 to 80.6)	4.5 (0.6 to 15.5)	0.0 (0.0 to 52.2)	30.0 (11.9 to 54.3)	0.0 (0.0 to 45.9)

No statistical analyses for this end point

Secondary: Part 3: ORR

Top of page

End point title

Part 3: ORR ^[10]

End point description

ORR was defined as the percentage of participants with a best overall response of CR or PR, per RECIST version 1.1, as determined by the investigator. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

End point type

Secondary

End point timeframe

up to 203 days

Notes
[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: Statistical analysis was not conducted.

End point values	Part 3: Gem/Cis/intermittent pemigatinib 9 mg	Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg	Part 3: Tras/intermittent pemigatinib 13.5 mg	Part 3: Doc/intermittent pemigatinib 13.5 mg	Part 3: Pem/intermittent pemigatinib 9 mg	Part 3: Pem/intermittent pemigatinib 13.5 mg	Part 3: Pem/continuous pemigatinib 13.5 mg	Part 3: Ref/continuous pemigatinib 9 mg	Part 3: Ref/continuous pemigatinib 13.5 mg	Part 3: Ref/continuous pemigatinib 20 mg
Number of subjects analysed	1	7	6	7	3	14	9	7	9	2
Units: percentage of participants
number (confidence interval 95%)	0.0 (0.0 to 97.5)	42.9 (9.9 to 81.6)	0.0 (0.0 to 45.9)	14.3 (0.4 to 57.9)	0.0 (0.0 to 70.8)	28.6 (8.4 to 58.1)	33.3 (7.5 to 70.1)	0.0 (0.0 to 41.0)	22.2 (2.8 to 60.0)	0.0 (0.0 to 84.2)

No statistical analyses for this end point

Secondary: Parts 1 and 2: Cmax after once daily dosing of pemigatinib as monotherapy on Cycle 1 Day 1

Top of page

End point title

Parts 1 and 2: Cmax after once daily dosing of pemigatinib as monotherapy on Cycle 1 Day 1 ^[11]

End point description

Cmax was defined as the maximum observed plasma concentration. 9999 denotes that a standard deviation was not calculated for a single participant.

End point type

Secondary

End point timeframe

Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1

Notes
[11] - 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: Statistical analysis was not conducted.

End point values	Part 1: Intermittent pemigatinib 6 mg QD	Part 1: Intermittent pemigatinib 1 mg QD	Part 1: Intermittent pemigatinib 2 mg QD	Part 1: Intermittent pemigatinib 4 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 9 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 13.5 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 20 mg QD
Number of subjects analysed	4	1	1	1	21	69	69
Units: nanograms per milliliter (ng/mL)
arithmetic mean (standard deviation)	64.6 ( 9.16 )	25.3 ( 9999 )	13.6 ( 9999 )	109 ( 9999 )	139 ( 79.8 )	196 ( 121 )	300 ( 135 )

No statistical analyses for this end point

Secondary: Parts 1 and 2: tmax after once daily dosing of pemigatinib as monotherapy on Cycle 1 Day 1

Top of page

End point title

Parts 1 and 2: tmax after once daily dosing of pemigatinib as monotherapy on Cycle 1 Day 1 ^[12]

End point description

tmax was defined as the time to the maximum observed plasma concentration. -9999 and 9999 denote that a range was not calculated for a single participant.

End point type

Secondary

End point timeframe

Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1

Notes
[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: Statistical analysis was not conducted.

End point values	Part 1: Intermittent pemigatinib 6 mg QD	Part 1: Intermittent pemigatinib 1 mg QD	Part 1: Intermittent pemigatinib 2 mg QD	Part 1: Intermittent pemigatinib 4 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 9 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 13.5 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 20 mg QD
Number of subjects analysed	4	1	1	1	21	69	69
Units: hours (hr)
median (full range (min-max))	1.14 (1.00 to 2.08)	1 (-9999 to 9999)	5.92 (-9999 to 9999)	2.02 (-9999 to 9999)	1.17 (0.500 to 2.13)	1.20 (0.400 to 26.1)	1.98 (0.500 to 22.9)

No statistical analyses for this end point

Secondary: Parts 1 and 2: AUClast after once daily dosing of pemigatinib as monotherapy on Cycle 1 Day 1

Top of page

End point title

Parts 1 and 2: AUClast after once daily dosing of pemigatinib as monotherapy on Cycle 1 Day 1 ^[13]

End point description

AUClast was defined as the area under the plasma or serum concentration-time curve from the time of dosing to the last measurable concentration. 9999 denotes that a standard deviation was not calculated for a single participant.

End point type

Secondary

End point timeframe

Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1

Notes
[13] - 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: Statistical analysis was not conducted.

End point values	Part 1: Intermittent pemigatinib 6 mg QD	Part 1: Intermittent pemigatinib 1 mg QD	Part 1: Intermittent pemigatinib 2 mg QD	Part 1: Intermittent pemigatinib 4 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 9 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 13.5 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 20 mg QD
Number of subjects analysed	4	1	1	1	21	69	69
Units: hr*ng/mL
arithmetic mean (standard deviation)	641 ( 116 )	190 ( 9999 )	68.8 ( 9999 )	1010 ( 9999 )	1140 ( 498 )	1820 ( 1210 )	2510 ( 935 )

No statistical analyses for this end point

Secondary: Parts 1 and 2: AUC0-24 after once daily dosing of pemigatinib as monotherapy on Cycle 1 Day 1

Top of page

End point title

Parts 1 and 2: AUC0-24 after once daily dosing of pemigatinib as monotherapy on Cycle 1 Day 1 ^[14]

End point description

AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose. 9999 denotes that a standard deviation was not calculated for a single participant.

End point type

Secondary

End point timeframe

Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1

Notes
[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: Statistical analysis was not conducted.

End point values	Part 1: Intermittent pemigatinib 6 mg QD	Part 1: Intermittent pemigatinib 1 mg QD	Part 1: Intermittent pemigatinib 2 mg QD	Part 1: Intermittent pemigatinib 4 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 9 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 13.5 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 20 mg QD
Number of subjects analysed	4	1	1	1	21	69	69
Units: hr*ng/mL
arithmetic mean (standard deviation)	644 ( 115 )	191 ( 9999 )	9999 ( 9999 )	1010 ( 9999 )	1150 ( 497 )	1840 ( 1080 )	2850 ( 1050 )

No statistical analyses for this end point

Secondary: Parts 1 and 2: Cmax after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Top of page

End point title

Parts 1 and 2: Cmax after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state) ^[15]

End point description

Cmax was defined as the maximum observed plasma concentration. 9999 denotes that a standard deviation was not calculated for a single participant.

End point type

Secondary

End point timeframe

Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

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: Statistical analysis was not conducted for all treatment group comparisons

End point values	Part 1: Intermittent pemigatinib 6 mg QD	Part 1: Intermittent pemigatinib 1 mg QD	Part 1: Intermittent pemigatinib 2 mg QD	Part 1: Intermittent pemigatinib 4 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 9 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 13.5 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 20 mg QD
Number of subjects analysed	4	1	1	1	18	57	13
Units: ng/mL
arithmetic mean (standard deviation)	86.1 ( 38.0 )	26.2 ( 9999 )	22.9 ( 9999 )	103 ( 9999 )	196 ( 123 )	271 ( 151 )	449 ( 172 )

ANOVA of log-transformed, dose-normalized data

Statistical analysis description

pairwise p-values from a 1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)

Comparison groups

Part 1: Intermittent pemigatinib 6 mg QD v Parts 1 and 2: Intermittent/continuous pemigatinib 9 mg QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2841

Method

ANOVA

Confidence interval

ANOVA of log-transformed, dose-normalized data

Statistical analysis description

pairwise p-values from a 1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)

Comparison groups

Part 1: Intermittent pemigatinib 6 mg QD v Parts 1 and 2: Intermittent/continuous pemigatinib 13.5 mg QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

= 0.3042

Method

ANOVA

Confidence interval

ANOVA of log-transformed, dose-normalized data

Statistical analysis description

pairwise p-values from a 1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)

Comparison groups

Parts 1 and 2: Intermittent/continuous pemigatinib 9 mg QD v Parts 1 and 2: Intermittent/continuous pemigatinib 20 mg QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

= 0.4315

Method

ANOVA

Confidence interval

ANOVA of log-transformed, dose-normalized data

Statistical analysis description

pairwise p-values from a 1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)

Comparison groups

Parts 1 and 2: Intermittent/continuous pemigatinib 9 mg QD v Parts 1 and 2: Intermittent/continuous pemigatinib 13.5 mg QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

= 0.8214

Method

ANOVA

Confidence interval

ANOVA of log-transformed, dose-normalized data

Statistical analysis description

pairwise p-values from a 1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)

Comparison groups

Parts 1 and 2: Intermittent/continuous pemigatinib 13.5 mg QD v Parts 1 and 2: Intermittent/continuous pemigatinib 20 mg QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2595

Method

ANOVA

Confidence interval

ANOVA of log-transformed, dose-normalized data

Statistical analysis description

pairwise p-values from a 1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)

Comparison groups

Part 1: Intermittent pemigatinib 6 mg QD v Parts 1 and 2: Intermittent/continuous pemigatinib 20 mg QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1259

Method

ANOVA

Confidence interval

Secondary: Parts 1 and 2: tmax after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Top of page

End point title

Parts 1 and 2: tmax after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state) ^[16]

End point description

tmax was defined as the time to the maximum observed plasma concentration. -9999 and 9999 denote that a range was not calculated for a single participant.

End point type

Secondary

End point timeframe

Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

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: Statistical analysis was not conducted.

End point values	Part 1: Intermittent pemigatinib 6 mg QD	Part 1: Intermittent pemigatinib 1 mg QD	Part 1: Intermittent pemigatinib 2 mg QD	Part 1: Intermittent pemigatinib 4 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 9 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 13.5 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 20 mg QD
Number of subjects analysed	4	1	1	1	18	57	13
Units: hr
median (full range (min-max))	1.58 (0.983 to 23.7)	1.07 (-9999 to 9999)	3.98 (-9999 to 9999)	2.02 (-9999 to 9999)	1.00 (0.500 to 6.10)	1.13 (0.500 to 6.00)	1.12 (0.517 to 5.90)

No statistical analyses for this end point

Secondary: Parts 1 and 2: t1/2 after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Top of page

End point title

Parts 1 and 2: t1/2 after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state) ^[17]

End point description

t1/2 was defined as the apparent plasma terminal phase disposition half-life. 9999 denotes that a standard deviation was not calculated for a single participant.

End point type

Secondary

End point timeframe

Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

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: Statistical analysis was not conducted.

End point values	Part 1: Intermittent pemigatinib 6 mg QD	Part 1: Intermittent pemigatinib 1 mg QD	Part 1: Intermittent pemigatinib 2 mg QD	Part 1: Intermittent pemigatinib 4 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 9 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 13.5 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 20 mg QD
Number of subjects analysed	4	1	1	1	18	57	13
Units: hr
arithmetic mean (standard deviation)	21.0 ( 22.8 )	10.9 ( 9999 )	18.1 ( 9999 )	30.4 ( 9999 )	17.2 ( 9.70 )	17.4 ( 9.64 )	13.1 ( 6.01 )

No statistical analyses for this end point

Secondary: Parts 1 and 2: Cmin after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Top of page

End point title

Parts 1 and 2: Cmin after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state) ^[18]

End point description

Cmin was defined as the minimum observed plasma concentration over the dose interval. 9999 denotes that a standard deviation was not calculated for a single participant.

End point type

Secondary

End point timeframe

Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

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: Statistical analysis was not conducted.

End point values	Part 1: Intermittent pemigatinib 6 mg QD	Part 1: Intermittent pemigatinib 1 mg QD	Part 1: Intermittent pemigatinib 2 mg QD	Part 1: Intermittent pemigatinib 4 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 9 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 13.5 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 20 mg QD
Number of subjects analysed	4	1	1	1	18	57	13
Units: ng/mL
arithmetic mean (standard deviation)	30.0 ( 15.1 )	3.24 ( 9999 )	7.87 ( 9999 )	23.9 ( 9999 )	49.9 ( 49.6 )	71.7 ( 56.7 )	104 ( 93.3 )

No statistical analyses for this end point

Secondary: Parts 1 and 2: AUC0-24 after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Top of page

End point title

Parts 1 and 2: AUC0-24 after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state) ^[19]

End point description

End point type

Secondary

End point timeframe

Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

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: Statistical analysis was not conducted for all treatment group comparisons

End point values	Part 1: Intermittent pemigatinib 6 mg QD	Part 1: Intermittent pemigatinib 1 mg QD	Part 1: Intermittent pemigatinib 2 mg QD	Part 1: Intermittent pemigatinib 4 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 9 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 13.5 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 20 mg QD
Number of subjects analysed	4	1	1	1	18	57	13
Units: hr*ng/mL
arithmetic mean (standard deviation)	1080 ( 301 )	208 ( 9999 )	322 ( 9999 )	1380 ( 9999 )	2180 ( 1630 )	3010 ( 1890 )	4350 ( 1480 )

ANOVA of log-transformed, dose-normalized data

Statistical analysis description

pairwise p-values from a 1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)

Comparison groups

Part 1: Intermittent pemigatinib 6 mg QD v Parts 1 and 2: Intermittent/continuous pemigatinib 9 mg QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

= 0.8577

Method

ANOVA

Confidence interval

ANOVA of log-transformed, dose-normalized data

Statistical analysis description

pairwise p-values from a 1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)

Comparison groups

Part 1: Intermittent pemigatinib 6 mg QD v Parts 1 and 2: Intermittent/continuous pemigatinib 13.5 mg QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

= 0.7238

Method

ANOVA

Confidence interval

ANOVA of log-transformed, dose-normalized data

Statistical analysis description

pairwise p-values from a 1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)

Comparison groups

Part 1: Intermittent pemigatinib 6 mg QD v Parts 1 and 2: Intermittent/continuous pemigatinib 20 mg QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

= 0.5923

Method

ANOVA

Confidence interval

ANOVA of log-transformed, dose-normalized data

Statistical analysis description

pairwise p-values from a 1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)

Comparison groups

Parts 1 and 2: Intermittent/continuous pemigatinib 9 mg QD v Parts 1 and 2: Intermittent/continuous pemigatinib 13.5 mg QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

= 0.7634

Method

ANOVA

Confidence interval

ANOVA of log-transformed, dose-normalized data

Statistical analysis description

pairwise p-values from a 1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)

Comparison groups

Parts 1 and 2: Intermittent/continuous pemigatinib 9 mg QD v Parts 1 and 2: Intermittent/continuous pemigatinib 20 mg QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

= 0.5749

Method

ANOVA

Confidence interval

ANOVA of log-transformed, dose-normalized data

Statistical analysis description

pairwise p-values from a 1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)

Comparison groups

Parts 1 and 2: Intermittent/continuous pemigatinib 13.5 mg QD v Parts 1 and 2: Intermittent/continuous pemigatinib 20 mg QD

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

= 0.6877

Method

ANOVA

Confidence interval

Secondary: Parts 1 and 2: CL/F after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Top of page

End point title

Parts 1 and 2: CL/F after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state) ^[20]

End point description

CL/F was defined as the apparent oral dose clearance. 9999 denotes that a standard deviation was not calculated for a single participant.

End point type

Secondary

End point timeframe

Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

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: Statistical analysis was not conducted.

End point values	Part 1: Intermittent pemigatinib 6 mg QD	Part 1: Intermittent pemigatinib 1 mg QD	Part 1: Intermittent pemigatinib 2 mg QD	Part 1: Intermittent pemigatinib 4 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 9 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 13.5 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 20 mg QD
Number of subjects analysed	4	1	1	1	18	57	13
Units: Liters per hr (L/hr)
arithmetic mean (standard deviation)	12.0 ( 3.14 )	9.86 ( 9999 )	12.8 ( 9999 )	5.93 ( 9999 )	15.7 ( 17.7 )	11.9 ( 5.72 )	10.3 ( 3.01 )

No statistical analyses for this end point

Secondary: Parts 1 and 2: Vz/F after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Top of page

End point title

Parts 1 and 2: Vz/F after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state) ^[21]

End point description

Vz/F was defined as the apparent volume of distribution. 9999 denotes that a standard deviation was not calculated for a single participant.

End point type

Secondary

End point timeframe

Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

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: Statistical analysis was not conducted.

End point values	Part 1: Intermittent pemigatinib 6 mg QD	Part 1: Intermittent pemigatinib 1 mg QD	Part 1: Intermittent pemigatinib 2 mg QD	Part 1: Intermittent pemigatinib 4 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 9 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 13.5 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 20 mg QD
Number of subjects analysed	4	1	1	1	18	57	13
Units: Liters
arithmetic mean (standard deviation)	301 ( 241 )	156 ( 9999 )	334 ( 9999 )	260 ( 9999 )	246 ( 76.1 )	274 ( 165 )	180 ( 49.1 )

No statistical analyses for this end point

Secondary: Parts 1 and 2: Accumulation ratio after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Top of page

End point title

Parts 1 and 2: Accumulation ratio after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state) ^[22]

End point description

The accumulation ratio was defined as the ratio of the accumulation of a drug under steady-state conditions as compared to a single dose. 9999 denotes that a standard deviation was not calculated for a single participant.

End point type

Secondary

End point timeframe

Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

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: Statistical analysis was not conducted.

End point values	Part 1: Intermittent pemigatinib 6 mg QD	Part 1: Intermittent pemigatinib 1 mg QD	Part 1: Intermittent pemigatinib 2 mg QD	Part 1: Intermittent pemigatinib 4 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 9 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 13.5 mg QD	Parts 1 and 2: Intermittent/continuous pemigatinib 20 mg QD
Number of subjects analysed	4	1	1	1	18	57	13
Units: ratio
arithmetic mean (standard deviation)	1.67 ( 0.264 )	1.09 ( 9999 )	1.64 ( 9999 )	1.36 ( 9999 )	1.71 ( 0.534 )	1.69 ( 0.538 )	1.76 ( 0.476 )

No statistical analyses for this end point

Secondary: Parts 1 and 2: Cmax steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

Top of page

End point title

Parts 1 and 2: Cmax steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

End point description

Cmax was defined as the maximum observed plasma concentration.

End point type

Secondary

End point timeframe

Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14

End point values	Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fasted	Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fed
Number of subjects analysed	12	12
Units: ng/mL
arithmetic mean (standard deviation)	215 ( 86.5 )	179 ( 82.8 )

crossover ANOVA of log-transformed data

Comparison groups

Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fasted v Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fed

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

= 0.143

Method

ANOVA

Confidence interval

Secondary: Parts 1 and 2: tmax steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

Top of page

End point title

Parts 1 and 2: tmax steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

End point description

tmax was defined as the time to the maximum observed plasma concentration.

End point type

Secondary

End point timeframe

Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14

End point values	Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fasted	Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fed
Number of subjects analysed	12	12
Units: hr
median (full range (min-max))	1.58 (0.500 to 5.78)	4.02 (1.00 to 7.58)

crossover ANOVA of log-transformed data

Comparison groups

Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fasted v Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fed

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0013

Method

ANOVA

Confidence interval

Secondary: Parts 1 and 2: t1/2 steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

Top of page

End point title

Parts 1 and 2: t1/2 steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

End point description

t1/2 was defined as the apparent plasma terminal phase disposition half-life.

End point type

Secondary

End point timeframe

Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14

End point values	Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fasted	Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fed
Number of subjects analysed	12	12
Units: hr
arithmetic mean (standard deviation)	19.2 ( 10.5 )	23.8 ( 17.5 )

crossover ANOVA of log-transformed data

Comparison groups

Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fasted v Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fed

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

= 0.319

Method

ANOVA

Confidence interval

Secondary: Parts 1 and 2: Cmin steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

Top of page

End point title

Parts 1 and 2: Cmin steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

End point description

Cmin was defined as the minimum observed plasma concentration over the dose interval.

End point type

Secondary

End point timeframe

Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14

End point values	Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fasted	Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fed
Number of subjects analysed	12	12
Units: ng/mL
arithmetic mean (standard deviation)	61.1 ( 33.5 )	65.7 ( 34.7 )

crossover ANOVA of log-transformed data

Comparison groups

Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fasted v Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fed

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

= 0.128

Method

ANOVA

Confidence interval

Secondary: Parts 1 and 2: AUC0-24 steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

Top of page

End point title

Parts 1 and 2: AUC0-24 steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

End point description

AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.

End point type

Secondary

End point timeframe

Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14

End point values	Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fasted	Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fed
Number of subjects analysed	12	12
Units: hr*ng/mL
arithmetic mean (standard deviation)	2580 ( 999 )	2910 ( 1310 )

crossover ANOVA of log-transformed data

Comparison groups

Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fasted v Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fed

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

= 0.305

Method

ANOVA

Confidence interval

Secondary: Parts 1 and 2: CL/F steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

Top of page

End point title

Parts 1 and 2: CL/F steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

End point description

CL/F was defined as the apparent oral dose clearance.

End point type

Secondary

End point timeframe

Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14

End point values	Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fasted	Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fed
Number of subjects analysed	12	12
Units: L/hr
arithmetic mean (standard deviation)	12.4 ( 4.94 )	11.3 ( 4.87 )

crossover ANOVA of log-transformed data

Comparison groups

Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fasted v Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fed

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

= 0.305

Method

ANOVA

Confidence interval

Secondary: Parts 1 and 2: Vz/F steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

Top of page

End point title

Parts 1 and 2: Vz/F steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

End point description

Vz/F was defined as the apparent volume of distribution.

End point type

Secondary

End point timeframe

Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14

End point values	Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fasted	Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fed
Number of subjects analysed	12	12
Units: Liters
arithmetic mean (standard deviation)	307 ( 139 )	364 ( 262 )

crossover ANOVA of log-transformed data

Comparison groups

Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fasted v Part 2: intermittent/continuous pemigatinib 13.5 mg QD, fed

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

P-value

= 0.772

Method

ANOVA

Confidence interval

Secondary: Part 3: Cmax of pemigatinib as part of combination therapy on Cycle 1 Day 1

Top of page

End point title

Part 3: Cmax of pemigatinib as part of combination therapy on Cycle 1 Day 1 ^[23]

End point description

Cmax was defined as the maximum observed plasma concentration.

End point type

Secondary

End point timeframe

predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1

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: Statistical analysis was not conducted.

End point values	Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg	Part 3: Tras/intermittent pemigatinib 13.5 mg	Part 3: Doc/intermittent pemigatinib 13.5 mg	Part 3: Pem/intermittent pemigatinib 9 mg	Part 3: Pem/intermittent pemigatinib 13.5 mg
Number of subjects analysed	7	6	7	3	19
Units: ng/mL
arithmetic mean (standard deviation)	234 ( 84.1 )	259 ( 55.4 )	214 ( 98.2 )	137 ( 65.7 )	199 ( 99.6 )

No statistical analyses for this end point

Secondary: Part 3: tmax of pemigatinib as part of combination therapy on Cycle 1 Day 1

Top of page

End point title

Part 3: tmax of pemigatinib as part of combination therapy on Cycle 1 Day 1 ^[24]

End point description

tmax was defined as the time to the maximum observed plasma concentration.

End point type

Secondary

End point timeframe

predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1

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: Statistical analysis was not conducted.

End point values	Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg	Part 3: Tras/intermittent pemigatinib 13.5 mg	Part 3: Doc/intermittent pemigatinib 13.5 mg	Part 3: Pem/intermittent pemigatinib 9 mg	Part 3: Pem/intermittent pemigatinib 13.5 mg
Number of subjects analysed	7	6	7	3	19
Units: hr
median (full range (min-max))	2.00 (0.500 to 22.6)	0.783 (0.500 to 18.6)	1.00 (0.500 to 3.98)	1.98 (1.00 to 4.00)	1.05 (0.500 to 23.4)

No statistical analyses for this end point

Secondary: Part 3: AUClast of pemigatinib as part of combination therapy on Cycle 1 Day 1

Top of page

End point title

Part 3: AUClast of pemigatinib as part of combination therapy on Cycle 1 Day 1 ^[25]

End point description

AUClast was defined as the area under the plasma or serum concentration-time curve from the time of dosing to the last measurable concentration.

End point type

Secondary

End point timeframe

predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1

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: Statistical analysis was not conducted.

End point values	Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg	Part 3: Tras/intermittent pemigatinib 13.5 mg	Part 3: Doc/intermittent pemigatinib 13.5 mg	Part 3: Pem/intermittent pemigatinib 9 mg	Part 3: Pem/intermittent pemigatinib 13.5 mg
Number of subjects analysed	7	6	7	3	19
Units: hr*ng/mL
arithmetic mean (standard deviation)	2890 ( 1010 )	2040 ( 513 )	1890 ( 491 )	1480 ( 587 )	1880 ( 821 )

No statistical analyses for this end point

Secondary: Part 3: AUC0-24 of pemigatinib as part of combination therapy on Cycle 1 Day 1

Top of page

End point title

Part 3: AUC0-24 of pemigatinib as part of combination therapy on Cycle 1 Day 1 ^[26]

End point description

AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.

End point type

Secondary

End point timeframe

predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1

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: Statistical analysis was not conducted.

End point values	Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg	Part 3: Tras/intermittent pemigatinib 13.5 mg	Part 3: Doc/intermittent pemigatinib 13.5 mg	Part 3: Pem/intermittent pemigatinib 9 mg	Part 3: Pem/intermittent pemigatinib 13.5 mg
Number of subjects analysed	7	6	7	3	19
Units: hr*ng/mL
arithmetic mean (standard deviation)	2920 ( 1070 )	1890 ( 269 )	1890 ( 471 )	1550 ( 552 )	1910 ( 838 )

No statistical analyses for this end point

Secondary: Part 3: Cmax of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state)

Top of page

End point title

Part 3: Cmax of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state) ^[27]

End point description

Cmax was defined as the maximum observed plasma concentration.

End point type

Secondary

End point timeframe

predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

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: Statistical analysis was not conducted.

End point values	Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg	Part 3: Tras/intermittent pemigatinib 13.5 mg	Part 3: Doc/intermittent pemigatinib 13.5 mg	Part 3: Pem/intermittent pemigatinib 9 mg	Part 3: Pem/intermittent pemigatinib 13.5 mg
Number of subjects analysed	4	5	5	3	14
Units: ng/mL
arithmetic mean (standard deviation)	214 ( 203 )	404 ( 41.7 )	231 ( 99.4 )	166 ( 52.1 )	255 ( 119 )

No statistical analyses for this end point

Secondary: Part 3: tmax of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state)

Top of page

End point title

Part 3: tmax of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state) ^[28]

End point description

tmax was defined as the time to the maximum observed plasma concentration.

End point type

Secondary

End point timeframe

predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

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: Statistical analysis was not conducted.

End point values	Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg	Part 3: Tras/intermittent pemigatinib 13.5 mg	Part 3: Doc/intermittent pemigatinib 13.5 mg	Part 3: Pem/intermittent pemigatinib 9 mg	Part 3: Pem/intermittent pemigatinib 13.5 mg
Number of subjects analysed	4	5	5	3	14
Units: hr
median (full range (min-max))	1.50 (0.950 to 4.00)	0.583 (0.500 to 1.07)	1.90 (0.500 to 2.08)	5.78 (1.25 to 6.08)	1.08 (0.500 to 7.98)

No statistical analyses for this end point

Secondary: Part 3: t1/2 of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state)

Top of page

End point title

Part 3: t1/2 of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state) ^[29]

End point description

t1/2 was defined as the apparent plasma terminal phase disposition half-life. 9999 denotes that a standard deviation was not calculated for a single participant.

End point type

Secondary

End point timeframe

predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

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: Statistical analysis was not conducted.

End point values	Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg	Part 3: Tras/intermittent pemigatinib 13.5 mg	Part 3: Doc/intermittent pemigatinib 13.5 mg	Part 3: Pem/intermittent pemigatinib 9 mg	Part 3: Pem/intermittent pemigatinib 13.5 mg
Number of subjects analysed	4	5	5	3	14
Units: hr
arithmetic mean (standard deviation)	10.6 ( 3.29 )	15.3 ( 2.64 )	14.7 ( 6.43 )	15.3 ( 0.207 )	17.0 ( 6.90 )

No statistical analyses for this end point

Secondary: Part 3: Cmin of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state)

Top of page

End point title

Part 3: Cmin of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state) ^[30]

End point description

Cmin was defined as the minimum observed plasma concentration over the dose interval.

End point type

Secondary

End point timeframe

predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

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: Statistical analysis was not conducted.

End point values	Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg	Part 3: Tras/intermittent pemigatinib 13.5 mg	Part 3: Doc/intermittent pemigatinib 13.5 mg	Part 3: Pem/intermittent pemigatinib 9 mg	Part 3: Pem/intermittent pemigatinib 13.5 mg
Number of subjects analysed	4	5	5	3	14
Units: ng/mL
arithmetic mean (standard deviation)	48.5 ( 57.8 )	64.2 ( 25.8 )	63.1 ( 32.4 )	58.0 ( 31.6 )	56.6 ( 31.3 )

No statistical analyses for this end point

Secondary: Part 3: AUC0-24 of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state)

Top of page

End point title

Part 3: AUC0-24 of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state) ^[31]

End point description

AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.

End point type

Secondary

End point timeframe

predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

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: Statistical analysis was not conducted.

End point values	Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg	Part 3: Tras/intermittent pemigatinib 13.5 mg	Part 3: Doc/intermittent pemigatinib 13.5 mg	Part 3: Pem/intermittent pemigatinib 9 mg	Part 3: Pem/intermittent pemigatinib 13.5 mg
Number of subjects analysed	4	5	5	3	14
Units: hr*ng/mL
arithmetic mean (standard deviation)	1650 ( 1060 )	3440 ( 672 )	2910 ( 1390 )	2400 ( 628 )	2400 ( 967 )

No statistical analyses for this end point

Secondary: Part 3: CL/F of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state)

Top of page

End point title

Part 3: CL/F of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state) ^[32]

End point description

CL/F was defined as the apparent oral dose clearance.

End point type

Secondary

End point timeframe

predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

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: Statistical analysis was not conducted.

End point values	Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg	Part 3: Tras/intermittent pemigatinib 13.5 mg	Part 3: Doc/intermittent pemigatinib 13.5 mg	Part 3: Pem/intermittent pemigatinib 9 mg	Part 3: Pem/intermittent pemigatinib 13.5 mg
Number of subjects analysed	4	5	5	3	14
Units: L/hr
arithmetic mean (standard deviation)	24.5 ( 17.7 )	8.26 ( 1.39 )	12.7 ( 9.03 )	8.03 ( 1.89 )	13.4 ( 5.46 )

No statistical analyses for this end point

Secondary: Part 3: Vz/F of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state)

Top of page

End point title

Part 3: Vz/F of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state) ^[33]

End point description

Vz/F was defined as the apparent volume of distribution.

End point type

Secondary

End point timeframe

predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

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: Statistical analysis was not conducted.

End point values	Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg	Part 3: Tras/intermittent pemigatinib 13.5 mg	Part 3: Doc/intermittent pemigatinib 13.5 mg	Part 3: Pem/intermittent pemigatinib 9 mg	Part 3: Pem/intermittent pemigatinib 13.5 mg
Number of subjects analysed	4	5	5	3	14
Units: Liters
arithmetic mean (standard deviation)	376 ( 261 )	182 ( 43.2 )	227 ( 82.2 )	177 ( 39.8 )	303 ( 136 )

No statistical analyses for this end point

Secondary: Part 3: Accumulation ratio of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state)

Top of page

End point title

Part 3: Accumulation ratio of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state) ^[34]

End point description

The accumulation ratio was defined as the ratio of the accumulation of a drug under steady-state conditions as compared to a single dose.

End point type

Secondary

End point timeframe

predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

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: Statistical analysis was not conducted.

End point values	Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg	Part 3: Tras/intermittent pemigatinib 13.5 mg	Part 3: Doc/intermittent pemigatinib 13.5 mg	Part 3: Pem/intermittent pemigatinib 9 mg	Part 3: Pem/intermittent pemigatinib 13.5 mg
Number of subjects analysed	4	5	5	3	14
Units: ratio
arithmetic mean (standard deviation)	0.604 ( 0.265 )	1.90 ( 0.432 )	1.52 ( 0.772 )	1.65 ( 0.501 )	1.53 ( 0.381 )

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

up to 869 days

Adverse event reporting additional description

Treatment-emergent adverse events (TEAEs), defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, are reported for all enrolled participants who received at least 1 dose of study drug (Safety Population).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

Part 1: Intermittent pemigatinib 1/2/4 mg QD‌

Reporting group description

Participants self-administered oral pemigatinib 1/2/4 milligrams (mg) once daily (QD) on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Reporting group title

Part 1: Intermittent pemigatinib 6 mg QD‌

Reporting group description

Participants self-administered oral pemigatinib 6 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Reporting group title

Parts 1 and 2: Intermittent pemigatinib 9 mg QD‌

Reporting group description

Reporting group title

Parts 1 and 2: Intermittent pemigatinib 13.5 mg QD‌

Reporting group description

Reporting group title

Part 1: Intermittent pemigatinib 20 mg QD‌

Reporting group description

Participants self-administered oral pemigatinib 20 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Reporting group title

Parts 1 and 2: Continuous pemigatinib 9 mg QD‌

Reporting group description

Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.

Reporting group title

Parts 1 and 2: Continuous pemigatinib 13.5 mg QD‌

Reporting group description

Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.

Reporting group title

Parts 1 and 2: Continuous pemigatinib 20 mg QD‌

Reporting group description

Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.

Reporting group title

Part 1: Continuous pemigatinib 7.5 mg BID‌

Reporting group description

Participants self-administered oral pemigatinib 7.5 mg twice daily (BID) on Days 1 through 21 of each 21-day cycle.

Reporting group title

Part 1: Continuous pemigatinib 10 mg BID‌

Reporting group description

Participants self-administered oral pemigatinib 10 mg BID on Days 1 through 21 of each 21-day cycle.

Reporting group title

Part 3: Gem/Cis/intermittent pemigatinib 9 mg‌

Reporting group description

Reporting group title

Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg‌

Reporting group description

Reporting group title

Part 3: Tras/intermittent pemigatinib 13.5 mg‌

Reporting group description

Reporting group title

Part 3: Doc/intermittent pemigatinib 13.5 mg‌

Reporting group description

Reporting group title

Part 3: Pem/intermittent pemigatinib 9 mg‌

Reporting group description

Reporting group title

Part 3: Pem/intermittent pemigatinib 13.5 mg‌

Reporting group description

Reporting group title

Part 3: Pem/continuous pemigatinib 13.5 mg‌

Reporting group description

Participants received pembrolizumab intravenously at 200 mg once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.

Reporting group title

Part 3: Ref/continuous pemigatinib 9 mg‌

Reporting group description

Reporting group title

Part 3: Ref/continuous pemigatinib 13.5 mg‌

Reporting group description

Reporting group title

Part 3: Ref/continuous pemigatinib 20 mg‌

Reporting group description

Retifanlimab was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial intravenous dose of 500 mg. Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.

Part 1: Intermittent pemigatinib 1/2/4 mg QD‌

Part 1: Intermittent pemigatinib 6 mg QD‌

Parts 1 and 2: Intermittent pemigatinib 9 mg QD‌

Parts 1 and 2: Intermittent pemigatinib 13.5 mg QD‌

Part 1: Intermittent pemigatinib 20 mg QD‌

Parts 1 and 2: Continuous pemigatinib 9 mg QD‌

Parts 1 and 2: Continuous pemigatinib 13.5 mg QD‌

Parts 1 and 2: Continuous pemigatinib 20 mg QD‌

Part 1: Continuous pemigatinib 7.5 mg BID‌

Part 1: Continuous pemigatinib 10 mg BID‌

Part 3: Gem/Cis/intermittent pemigatinib 9 mg‌

Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg‌

Part 3: Tras/intermittent pemigatinib 13.5 mg‌

Part 3: Doc/intermittent pemigatinib 13.5 mg‌

Part 3: Pem/intermittent pemigatinib 9 mg‌

Part 3: Pem/intermittent pemigatinib 13.5 mg‌

Part 3: Pem/continuous pemigatinib 13.5 mg‌

Part 3: Ref/continuous pemigatinib 9 mg‌

Part 3: Ref/continuous pemigatinib 13.5 mg‌

Part 3: Ref/continuous pemigatinib 20 mg‌

Total subjects affected by serious adverse events

subjects affected / exposed

1 / 3 (33.33%)

0 / 4 (0.00%)

3 / 7 (42.86%)

21 / 50 (42.00%)

3 / 6 (50.00%)

6 / 14 (42.86%)

14 / 30 (46.67%)

7 / 15 (46.67%)

2 / 4 (50.00%)

2 / 3 (66.67%)

1 / 1 (100.00%)

3 / 7 (42.86%)

0 / 6 (0.00%)

6 / 7 (85.71%)

1 / 3 (33.33%)

7 / 14 (50.00%)

3 / 9 (33.33%)

4 / 7 (57.14%)

5 / 9 (55.56%)

2 / 2 (100.00%)

number of deaths (all causes)

number of deaths resulting from adverse events

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

Metastases to central nervous system

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metastases to spine

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metastatic neoplasm

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

1 / 9 (11.11%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular disorders

Haemorrhage

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 7 (14.29%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypertension

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

1 / 3 (33.33%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

1 / 14 (7.14%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

Hypotension

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

2 / 30 (6.67%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

1 / 14 (7.14%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Shock

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

General disorders and administration site conditions

Disease progression

subjects affected / exposed

1 / 3 (33.33%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

1 / 15 (6.67%)

0 / 4 (0.00%)

1 / 3 (33.33%)

0 / 1 (0.00%)

1 / 7 (14.29%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

1 / 9 (11.11%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

Facial pain

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Fatigue

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

3 / 30 (10.00%)

1 / 15 (6.67%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 7 (14.29%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

1 / 7 (14.29%)

0 / 9 (0.00%)

1 / 2 (50.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

1 / 3

2 / 2

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Gait disturbance

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

1 / 7 (14.29%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypothermia

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Mucosal inflammation

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Multiple organ dysfunction syndrome

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

Non-cardiac chest pain

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

1 / 3 (33.33%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Oedema

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

1 / 15 (6.67%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Oedema peripheral

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

1 / 15 (6.67%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pyrexia

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

2 / 50 (4.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

1 / 15 (6.67%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Systemic inflammatory response syndrome

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

Acute respiratory failure

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

Chronic obstructive pulmonary disease

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

1 / 6 (16.67%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Dyspnoea

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

1 / 15 (6.67%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

1 / 14 (7.14%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haemoptysis

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypoxia

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

Pleural effusion

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

1 / 15 (6.67%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

Pneumonia aspiration

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

Pneumonitis

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

1 / 9 (11.11%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumothorax

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

1 / 6 (16.67%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pulmonary embolism

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

1 / 6 (16.67%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 7 (14.29%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

Respiratory failure

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

1 / 14 (7.14%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

Psychiatric disorders

Completed suicide

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

1 / 3 (33.33%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

Mental status changes

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

1 / 14 (7.14%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

1 / 3 (33.33%)

0 / 1 (0.00%)

1 / 7 (14.29%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Product issues

Device occlusion

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Investigations

Blood alkaline phosphatase increased

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

Blood bilirubin increased

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Blood creatinine increased

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Blood osmolarity decreased

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Clostridium test positive

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Troponin I

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

1 / 9 (11.11%)

0 / 2 (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

Alcohol poisoning

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

1 / 9 (11.11%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

Fall

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

1 / 14 (7.14%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Femur fracture

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

1 / 14 (7.14%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Procedural pain

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Spinal compression fracture

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

1 / 14 (7.14%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Atrial fibrillation

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

1 / 9 (11.11%)

0 / 2 (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

Atrial flutter

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

1 / 9 (11.11%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Atrial thrombosis

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

1 / 15 (6.67%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac arrest

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac tamponade

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

Cerebrovascular accident

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

1 / 6 (16.67%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

Depressed level of consciousness

subjects affected / exposed

1 / 3 (33.33%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Dizziness

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

1 / 14 (7.14%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Dysarthria

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haemorrhage intracranial

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

Hydrocephalus

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 7 (14.29%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Myoclonus

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

1 / 3 (33.33%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Seizure

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Syncope

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

1 / 15 (6.67%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Blood and lymphatic system disorders

Anaemia

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

1 / 15 (6.67%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 7 (14.29%)

0 / 3 (0.00%)

1 / 14 (7.14%)

0 / 9 (0.00%)

0 / 7 (0.00%)

1 / 9 (11.11%)

1 / 2 (50.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

1 / 1

deaths causally related to treatment / all

0 / 0

Febrile neutropenia

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

1 / 1 (100.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Neutropenia

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Abdominal pain

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

2 / 50 (4.00%)

0 / 6 (0.00%)

1 / 14 (7.14%)

0 / 30 (0.00%)

1 / 15 (6.67%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Abdominal pain upper

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

1 / 14 (7.14%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Constipation

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

1 / 7 (14.29%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

1 / 15 (6.67%)

0 / 4 (0.00%)

0 / 3 (0.00%)

1 / 1 (100.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

Diarrhoea

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

1 / 14 (7.14%)

1 / 9 (11.11%)

0 / 7 (0.00%)

1 / 9 (11.11%)

0 / 2 (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

Dysphagia

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

1 / 14 (7.14%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

Enterocolitis

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 7 (14.29%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal haemorrhage

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

1 / 4 (25.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

0 / 1

0 / 0

Gastrooesophageal reflux disease

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

1 / 15 (6.67%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Large intestinal obstruction

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

1 / 9 (11.11%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Oesophagitis

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

1 / 9 (11.11%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rectal haemorrhage

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

2 / 50 (4.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

1 / 15 (6.67%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

1 / 7 (14.29%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

1 / 14 (7.14%)

0 / 9 (0.00%)

1 / 7 (14.29%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Upper gastrointestinal haemorrhage

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

1 / 14 (7.14%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Varices oesophageal

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

1 / 15 (6.67%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

0 / 1

0 / 0

Vomiting

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

1 / 15 (6.67%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

Hepatobiliary disorders

Cholangitis

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hyperbilirubinaemia

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Skin and subcutaneous tissue disorders

Erythema

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

Acute kidney injury

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

1 / 14 (7.14%)

3 / 30 (10.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

1 / 7 (14.29%)

0 / 6 (0.00%)

1 / 7 (14.29%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

1 / 7 (14.29%)

0 / 9 (0.00%)

2 / 2 (100.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 4

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

2 / 3

deaths causally related to treatment / all

0 / 0

Hydronephrosis

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal failure

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Endocrine disorders

Hypothyroidism

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

1 / 7 (14.29%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Inappropriate antidiuretic hormone secretion

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

1 / 3 (33.33%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

1 / 7 (14.29%)

0 / 9 (0.00%)

0 / 2 (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

Musculoskeletal and connective tissue disorders

Back pain

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

1 / 14 (7.14%)

2 / 30 (6.67%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Fistula

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Flank pain

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

1 / 7 (14.29%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal chest pain

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pain in extremity

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

2 / 30 (6.67%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Pathological fracture

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

1 / 9 (11.11%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

Vertebral osteophyte

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

Bronchitis

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Chronic sinusitis

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Clostridium difficile infection

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

1 / 9 (11.11%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Device related infection

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Escherichia bacteraemia

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastroenteritis

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

1 / 6 (16.67%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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 / 3 (0.00%)

0 / 4 (0.00%)

1 / 7 (14.29%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Meningitis bacterial

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 7 (14.29%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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

Oesophageal candidiasis

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

1 / 7 (14.29%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Paronychia

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

1 / 15 (6.67%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pharyngitis

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

2 / 7 (28.57%)

2 / 50 (4.00%)

1 / 6 (16.67%)

1 / 14 (7.14%)

1 / 30 (3.33%)

1 / 15 (6.67%)

2 / 4 (50.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

1 / 9 (11.11%)

0 / 7 (0.00%)

1 / 9 (11.11%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 1

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Sepsis

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

1 / 14 (7.14%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urinary tract infection

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

3 / 30 (10.00%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

1 / 14 (7.14%)

0 / 9 (0.00%)

0 / 7 (0.00%)

1 / 9 (11.11%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urosepsis

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

Dehydration

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

1 / 50 (2.00%)

0 / 6 (0.00%)

1 / 14 (7.14%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

1 / 7 (14.29%)

0 / 6 (0.00%)

2 / 7 (28.57%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

1 / 9 (11.11%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

1 / 2

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Electrolyte imbalance

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypercalcaemia

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

1 / 15 (6.67%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

1 / 7 (14.29%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Hyponatraemia

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

2 / 50 (4.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

2 / 30 (6.67%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Hypophagia

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 30 (0.00%)

1 / 15 (6.67%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolic alkalosis

subjects affected / exposed

0 / 3 (0.00%)

0 / 4 (0.00%)

0 / 7 (0.00%)

0 / 50 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 30 (3.33%)

0 / 15 (0.00%)

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

0 / 3 (0.00%)

0 / 14 (0.00%)

0 / 9 (0.00%)

0 / 7 (0.00%)

0 / 9 (0.00%)

0 / 2 (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	Part 1: Intermittent pemigatinib 1/2/4 mg QD‌	Part 1: Intermittent pemigatinib 6 mg QD‌	Parts 1 and 2: Intermittent pemigatinib 9 mg QD‌	Parts 1 and 2: Intermittent pemigatinib 13.5 mg QD‌	Part 1: Intermittent pemigatinib 20 mg QD‌	Parts 1 and 2: Continuous pemigatinib 9 mg QD‌	Parts 1 and 2: Continuous pemigatinib 13.5 mg QD‌	Parts 1 and 2: Continuous pemigatinib 20 mg QD‌	Part 1: Continuous pemigatinib 7.5 mg BID‌	Part 1: Continuous pemigatinib 10 mg BID‌	Part 3: Gem/Cis/intermittent pemigatinib 9 mg‌	Part 3: Gem/Cis/intermittent pemigatinib 13.5 mg‌	Part 3: Tras/intermittent pemigatinib 13.5 mg‌	Part 3: Doc/intermittent pemigatinib 13.5 mg‌	Part 3: Pem/intermittent pemigatinib 9 mg‌	Part 3: Pem/intermittent pemigatinib 13.5 mg‌	Part 3: Pem/continuous pemigatinib 13.5 mg‌	Part 3: Ref/continuous pemigatinib 9 mg‌	Part 3: Ref/continuous pemigatinib 13.5 mg‌	Part 3: Ref/continuous pemigatinib 20 mg‌
Total subjects affected by non serious adverse events
subjects affected / exposed	3 / 3 (100.00%)	3 / 4 (75.00%)	7 / 7 (100.00%)	50 / 50 (100.00%)	6 / 6 (100.00%)	14 / 14 (100.00%)	30 / 30 (100.00%)	15 / 15 (100.00%)	4 / 4 (100.00%)	3 / 3 (100.00%)	1 / 1 (100.00%)	7 / 7 (100.00%)	6 / 6 (100.00%)	7 / 7 (100.00%)	3 / 3 (100.00%)	14 / 14 (100.00%)	9 / 9 (100.00%)	7 / 7 (100.00%)	9 / 9 (100.00%)	2 / 2 (100.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Cancer pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0
Melanocytic naevus
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Metastases to central nervous system
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Pyogenic granuloma
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	2 / 30 (6.67%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	2	0	0	0	0	0	0	0	0	0	0	0	0	0
Seborrhoeic keratosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Skin papilloma
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Vascular disorders
Diastolic hypertension
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Hot flush
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0
Hypertension
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	2 / 30 (6.67%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	4	0	0	0	0	0	0	0	0	0	0	0	0	0
Hypotension
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	5 / 50 (10.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	6 / 30 (20.00%)	1 / 15 (6.67%)	1 / 4 (25.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	2 / 7 (28.57%)	1 / 3 (33.33%)	2 / 14 (14.29%)	0 / 9 (0.00%)	0 / 7 (0.00%)	2 / 9 (22.22%)	1 / 2 (50.00%)
occurrences all number	0	0	0	5	0	0	6	1	1	1	0	0	0	2	1	2	0	0	2	1
Systolic hypertension
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Thrombophlebitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Venous thrombosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	1 / 9 (11.11%)	2 / 7 (28.57%)	0 / 9 (0.00%)	1 / 2 (50.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	1	0	1	0	0	1	2	0	2
Catheter site pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Chest discomfort
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Chills
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 2 (50.00%)
occurrences all number	0	0	0	0	0	0	4	0	0	0	0	0	1	0	0	1	1	0	0	2
Fatigue
subjects affected / exposed	1 / 3 (33.33%)	1 / 4 (25.00%)	4 / 7 (57.14%)	18 / 50 (36.00%)	2 / 6 (33.33%)	8 / 14 (57.14%)	8 / 30 (26.67%)	4 / 15 (26.67%)	2 / 4 (50.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	5 / 7 (71.43%)	2 / 6 (33.33%)	5 / 7 (71.43%)	1 / 3 (33.33%)	5 / 14 (35.71%)	1 / 9 (11.11%)	3 / 7 (42.86%)	6 / 9 (66.67%)	0 / 2 (0.00%)
occurrences all number	1	1	4	21	2	8	8	5	3	0	0	5	2	6	1	5	1	3	10	0
Gait disturbance
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0
Generalised oedema
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Influenza like illness
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 2 (50.00%)
occurrences all number	0	0	0	1	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	1
Mucosal inflammation
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Non-cardiac chest pain
subjects affected / exposed	1 / 3 (33.33%)	0 / 4 (0.00%)	0 / 7 (0.00%)	2 / 50 (4.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	2 / 7 (28.57%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 2 (50.00%)
occurrences all number	1	0	0	2	0	0	0	0	0	0	0	2	0	1	0	0	0	0	0	1
Oedema peripheral
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	2 / 50 (4.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	4 / 30 (13.33%)	2 / 15 (13.33%)	0 / 4 (0.00%)	2 / 3 (66.67%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	2 / 7 (28.57%)	0 / 3 (0.00%)	1 / 14 (7.14%)	1 / 9 (11.11%)	0 / 7 (0.00%)	1 / 9 (11.11%)	1 / 2 (50.00%)
occurrences all number	0	0	0	2	0	1	4	3	0	2	0	1	0	2	0	1	1	0	1	1
Pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0
Performance status decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	2	3	0
Peripheral swelling
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Pyrexia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	2 / 14 (14.29%)	3 / 30 (10.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	2 / 6 (33.33%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	3 / 9 (33.33%)	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 2 (50.00%)
occurrences all number	0	0	0	1	0	3	6	0	0	0	0	0	2	0	0	1	3	0	0	2
Swelling face
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0
Tenderness
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Immune system disorders
Allergy to animal
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Drug hypersensitivity
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Hypersensitivity
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	2 / 14 (14.29%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	2	0	1	0	0	0	0	0	1	0	0	0	0	0	0
Reproductive system and breast disorders
Breast fibrosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Postmenopausal haemorrhage
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (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
Respiratory, thoracic and mediastinal disorders
Aspiration
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0
Cough
subjects affected / exposed	1 / 3 (33.33%)	0 / 4 (0.00%)	0 / 7 (0.00%)	6 / 50 (12.00%)	2 / 6 (33.33%)	2 / 14 (14.29%)	6 / 30 (20.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	4 / 6 (66.67%)	1 / 7 (14.29%)	0 / 3 (0.00%)	4 / 14 (28.57%)	2 / 9 (22.22%)	0 / 7 (0.00%)	2 / 9 (22.22%)	0 / 2 (0.00%)
occurrences all number	1	0	0	6	2	2	6	0	0	0	0	1	4	1	0	4	2	0	2	0
Dysphonia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	1 / 50 (2.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	2 / 30 (6.67%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	1	1	1	0	2	0	0	0	0	0	1	0	0	0	0	0	0	0
Dyspnoea
subjects affected / exposed	0 / 3 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	2 / 50 (4.00%)	1 / 6 (16.67%)	1 / 14 (7.14%)	3 / 30 (10.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	2 / 7 (28.57%)	2 / 6 (33.33%)	0 / 7 (0.00%)	1 / 3 (33.33%)	3 / 14 (21.43%)	1 / 9 (11.11%)	2 / 7 (28.57%)	2 / 9 (22.22%)	0 / 2 (0.00%)
occurrences all number	0	1	0	2	1	1	5	0	0	0	0	2	2	0	1	3	1	2	3	0
Dyspnoea exertional
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	1 / 30 (3.33%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 2 (50.00%)
occurrences all number	0	0	0	1	1	0	1	1	0	0	0	0	0	0	0	0	0	0	0	1
Epistaxis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	6 / 50 (12.00%)	1 / 6 (16.67%)	1 / 14 (7.14%)	4 / 30 (13.33%)	2 / 15 (13.33%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	2 / 6 (33.33%)	1 / 7 (14.29%)	0 / 3 (0.00%)	2 / 14 (14.29%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	1	7	1	2	4	2	0	0	0	0	2	2	0	2	0	1	0	0
Haemoptysis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Hiccups
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Hypoxia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	2	1	0	0	0	0	0	0	0	0	0	0	0	0
Nasal congestion
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0
Nasal discomfort
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Nasal dryness
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	2	0	0	1	1	0	0	0	0	0	1	0	0	1	0	0	0	0
Nasal septum deviation
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Oropharyngeal pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	5 / 50 (10.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	4 / 30 (13.33%)	3 / 15 (20.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	1 / 7 (14.29%)	0 / 3 (0.00%)	1 / 14 (7.14%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	9	0	0	6	3	0	0	0	0	1	1	0	1	1	0	0	0
Paranasal sinus discomfort
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Pharyngeal inflammation
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Pleural effusion
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	2 / 14 (14.29%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	2	0	1	0	1	0	0	1	0	0	0	0	0	1	0
Pneumonitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0
Productive cough
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	3 / 30 (10.00%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	1	1	0	0	3	0	1	0	0	0	0	0	0	0	1	0	0	0
Pulmonary embolism
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0
Rales
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Respiratory tract congestion
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Rhinitis allergic
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Rhinorrhoea
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 2 (50.00%)
occurrences all number	0	0	1	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1
Rhonchi
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Sinus disorder
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0
Sinus pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (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
Sneezing
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 2 (50.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1
Upper-airway cough syndrome
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0	0	0	1	0	0	0	0	0	0	0
Wheezing
subjects affected / exposed	0 / 3 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	1 / 6 (16.67%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	1	0	1	2	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Psychiatric disorders
Adjustment disorder with depressed mood
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Anxiety
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	4 / 50 (8.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	4 / 30 (13.33%)	1 / 15 (6.67%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	4	0	1	4	1	1	0	0	0	1	1	0	0	0	0	0	0
Confusional state
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 2 (50.00%)
occurrences all number	0	0	0	1	0	0	1	1	0	0	0	0	0	0	0	0	1	0	0	1
Depression
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	2 / 50 (4.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	3 / 30 (10.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	1 / 7 (14.29%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	2	0	0	3	0	0	0	0	0	1	1	0	1	0	0	0	0
Disorientation
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Insomnia
subjects affected / exposed	0 / 3 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	2 / 7 (28.57%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	1	0	1	0	0	1	0	0	0	0	1	0	0	0	1	0	2	2	0
Restlessness
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Investigations
Activated partial thromboplastin time prolonged
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	3	0	0	0	0	0	0	0	0	0	0	0	0	0
Alanine aminotransferase increased
subjects affected / exposed	1 / 3 (33.33%)	0 / 4 (0.00%)	1 / 7 (14.29%)	4 / 50 (8.00%)	0 / 6 (0.00%)	5 / 14 (35.71%)	7 / 30 (23.33%)	2 / 15 (13.33%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	4 / 7 (57.14%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	5 / 14 (35.71%)	3 / 9 (33.33%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	1	0	1	6	0	5	11	2	0	0	0	10	0	0	0	9	4	0	1	0
Amylase increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0
Aspartate aminotransferase increased
subjects affected / exposed	1 / 3 (33.33%)	0 / 4 (0.00%)	1 / 7 (14.29%)	7 / 50 (14.00%)	0 / 6 (0.00%)	5 / 14 (35.71%)	7 / 30 (23.33%)	3 / 15 (20.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	4 / 7 (57.14%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	5 / 14 (35.71%)	3 / 9 (33.33%)	0 / 7 (0.00%)	2 / 9 (22.22%)	0 / 2 (0.00%)
occurrences all number	2	0	1	8	0	5	10	4	0	0	0	9	1	0	0	10	4	0	4	0
Blood 1,25-dihydroxycholecalciferol decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	2	1	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0
Blood 1,25-dihydroxycholecalciferol increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Blood 25-hydroxycholecalciferol decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Blood alkaline phosphatase increased
subjects affected / exposed	1 / 3 (33.33%)	0 / 4 (0.00%)	2 / 7 (28.57%)	5 / 50 (10.00%)	0 / 6 (0.00%)	3 / 14 (21.43%)	1 / 30 (3.33%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	1 / 6 (16.67%)	1 / 7 (14.29%)	1 / 3 (33.33%)	2 / 14 (14.29%)	3 / 9 (33.33%)	0 / 7 (0.00%)	2 / 9 (22.22%)	0 / 2 (0.00%)
occurrences all number	1	0	3	7	0	3	1	0	2	0	0	2	1	1	1	5	4	0	2	0
Blood bilirubin increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0
Blood creatine increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Blood creatinine increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	2 / 50 (4.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	11 / 30 (36.67%)	4 / 15 (26.67%)	1 / 4 (25.00%)	0 / 3 (0.00%)	1 / 1 (100.00%)	4 / 7 (57.14%)	1 / 6 (16.67%)	1 / 7 (14.29%)	1 / 3 (33.33%)	4 / 14 (28.57%)	1 / 9 (11.11%)	1 / 7 (14.29%)	2 / 9 (22.22%)	2 / 2 (100.00%)
occurrences all number	0	0	1	3	0	0	18	4	4	0	1	6	1	1	1	7	1	2	5	4
Blood folate decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Blood glucose increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	2 / 7 (28.57%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	2	0	0	0	1	0	0	0	0	4	0	0	0	0	0	0	0	0
Blood phosphorus increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0
Blood thyroid stimulating hormone decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	2 / 14 (14.29%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Blood uric acid increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 2 (50.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Computerised tomogram abnormal
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Gamma-glutamyltransferase increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Lipase increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Liver function test increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Neutrophil count decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 1 (100.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	2	4	0	0	0	0	0	0	0	0
Neutrophil count increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Platelet count decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 1 (100.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	1	3	0	0	0	0	0	0	0	0
Urine analysis abnormal
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Vitamin B12 decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (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
Vitamin D decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	2 / 14 (14.29%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Vitamin D increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 1 (100.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0
Weight decreased
subjects affected / exposed	2 / 3 (66.67%)	0 / 4 (0.00%)	1 / 7 (14.29%)	5 / 50 (10.00%)	2 / 6 (33.33%)	3 / 14 (21.43%)	3 / 30 (10.00%)	5 / 15 (33.33%)	3 / 4 (75.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	3 / 7 (42.86%)	0 / 3 (0.00%)	1 / 14 (7.14%)	1 / 9 (11.11%)	1 / 7 (14.29%)	2 / 9 (22.22%)	1 / 2 (50.00%)
occurrences all number	2	0	1	5	2	3	3	7	3	1	0	1	0	4	0	2	1	1	2	1
Weight increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	1	0	0	4	1	0	0	0	0	0	0	0	0	0	0	0	1	0
White blood cell count decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 1 (100.00%)	3 / 7 (42.86%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	2	1	0	0	2	5	0	0	0	1	0	0	0	0
White blood cell count increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0
Injury, poisoning and procedural complications
Contusion
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Fall
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	3 / 50 (6.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	5 / 30 (16.67%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	1 / 14 (7.14%)	1 / 9 (11.11%)	1 / 7 (14.29%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	3	0	3	8	0	1	0	0	0	0	1	0	1	1	1	1	0
Infusion related reaction
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Limb injury
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0
Lip injury
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Nail avulsion
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0
Procedural pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	2	0	0	2	0	0	0	0	0	0	0	1	0	0	0	0	0
Skin abrasion
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	2 / 14 (14.29%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Tooth fracture
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Wound complication
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Congenital, familial and genetic disorders
Corneal dystrophy
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Cardiac disorders
Atrial thrombosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 2 (50.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Bradycardia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	2 / 50 (4.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	1	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Nodal rhythm
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (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
Palpitations
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Sinus tachycardia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	1	0	0	0	0
Tachycardia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	2 / 14 (14.29%)	1 / 30 (3.33%)	2 / 15 (13.33%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	1 / 2 (50.00%)
occurrences all number	0	0	0	0	0	2	1	2	0	0	0	0	0	0	0	0	0	0	1	1
Nervous system disorders
Ataxia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Dizziness
subjects affected / exposed	1 / 3 (33.33%)	1 / 4 (25.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	2 / 14 (14.29%)	4 / 30 (13.33%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	3 / 7 (42.86%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	1 / 14 (7.14%)	2 / 9 (22.22%)	2 / 7 (28.57%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	1	1	0	1	0	2	6	1	0	0	0	3	0	1	0	1	2	2	1	0
Dysarthria
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Dysgeusia
subjects affected / exposed	1 / 3 (33.33%)	0 / 4 (0.00%)	1 / 7 (14.29%)	5 / 50 (10.00%)	1 / 6 (16.67%)	2 / 14 (14.29%)	9 / 30 (30.00%)	4 / 15 (26.67%)	4 / 4 (100.00%)	2 / 3 (66.67%)	0 / 1 (0.00%)	2 / 7 (28.57%)	0 / 6 (0.00%)	3 / 7 (42.86%)	0 / 3 (0.00%)	2 / 14 (14.29%)	1 / 9 (11.11%)	1 / 7 (14.29%)	2 / 9 (22.22%)	0 / 2 (0.00%)
occurrences all number	1	0	1	5	1	2	9	5	4	2	0	2	0	3	0	2	1	1	3	0
Headache
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	2 / 50 (4.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	1 / 30 (3.33%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	2 / 6 (33.33%)	1 / 7 (14.29%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	2 / 7 (28.57%)	2 / 9 (22.22%)	1 / 2 (50.00%)
occurrences all number	0	0	0	2	2	0	1	1	0	0	0	1	2	1	0	1	0	3	2	1
Hyperaesthesia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Hypoaesthesia
subjects affected / exposed	0 / 3 (0.00%)	1 / 4 (25.00%)	1 / 7 (14.29%)	0 / 50 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	3 / 30 (10.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	1	1	0	1	0	3	0	0	0	0	0	0	1	0	0	0	0	0	0
Memory impairment
subjects affected / exposed	0 / 3 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	1	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Neuropathy peripheral
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	2 / 30 (6.67%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	2 / 7 (28.57%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	1	2	1	0	0	0	2	0	1	0	1	0	0	0	0
Paraesthesia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Presyncope
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0
Restless legs syndrome
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Seizure
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Somnolence
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 2 (50.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Syncope
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Taste disorder
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	4 / 50 (8.00%)	1 / 6 (16.67%)	2 / 14 (14.29%)	2 / 30 (6.67%)	2 / 15 (13.33%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	0 / 7 (0.00%)	2 / 6 (33.33%)	3 / 7 (42.86%)	0 / 3 (0.00%)	2 / 14 (14.29%)	3 / 9 (33.33%)	2 / 7 (28.57%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	2	4	1	2	2	2	0	1	0	0	2	3	0	3	3	2	0	0
Tremor
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0
Vocal cord paralysis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	1 / 3 (33.33%)	0 / 4 (0.00%)	1 / 7 (14.29%)	10 / 50 (20.00%)	2 / 6 (33.33%)	6 / 14 (42.86%)	6 / 30 (20.00%)	4 / 15 (26.67%)	2 / 4 (50.00%)	1 / 3 (33.33%)	1 / 1 (100.00%)	7 / 7 (100.00%)	2 / 6 (33.33%)	3 / 7 (42.86%)	1 / 3 (33.33%)	7 / 14 (50.00%)	3 / 9 (33.33%)	2 / 7 (28.57%)	0 / 9 (0.00%)	1 / 2 (50.00%)
occurrences all number	1	0	1	14	2	8	9	5	3	1	1	8	2	3	1	10	4	2	0	1
Iron deficiency anaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	1 / 15 (6.67%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	1 / 2 (50.00%)
occurrences all number	0	0	0	0	0	0	2	1	0	1	0	0	0	0	0	0	0	1	0	1
Leukopenia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	2 / 7 (28.57%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0	0	0	0
Lymph node pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Lymphadenopathy
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Lymphopenia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	2 / 50 (4.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	2 / 15 (13.33%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	1 / 6 (16.67%)	1 / 7 (14.29%)	0 / 3 (0.00%)	2 / 14 (14.29%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	2	0	0	1	3	0	0	0	1	1	1	0	2	0	0	0	0
Microcytic anaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 2 (50.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Neutropenia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	4 / 7 (57.14%)	0 / 6 (0.00%)	3 / 7 (42.86%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	9	0	6	0	0	0	0	0	0
Thrombocytopenia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	2 / 7 (28.57%)	4 / 50 (8.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	2 / 15 (13.33%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 1 (100.00%)	4 / 7 (57.14%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	3	6	0	1	0	2	0	0	1	9	0	0	0	0	0	0	0	0
Ear and labyrinth disorders
Cerumen impaction
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0
Deafness
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Ear congestion
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (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
Ear pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0
Excessive cerumen production
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Tinnitus
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Vertigo
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Eye disorders
Blepharitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	1	0	0	0	0
Blepharospasm
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Cataract
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Cataract cortical
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	2	0	0
Cataract nuclear
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	1	0	0	0	0
Cataract subcapsular
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0
Chorioretinopathy
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Conjunctival haemorrhage
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Corneal epithelium defect
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0
Detachment of macular retinal pigment epithelium
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Diplopia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Dry age-related macular degeneration
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Dry eye
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	8 / 50 (16.00%)	1 / 6 (16.67%)	1 / 14 (7.14%)	10 / 30 (33.33%)	4 / 15 (26.67%)	1 / 4 (25.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	0 / 7 (0.00%)	2 / 6 (33.33%)	1 / 7 (14.29%)	0 / 3 (0.00%)	4 / 14 (28.57%)	4 / 9 (44.44%)	0 / 7 (0.00%)	3 / 9 (33.33%)	0 / 2 (0.00%)
occurrences all number	0	0	0	9	1	2	11	4	1	1	0	0	2	1	0	4	4	0	3	0
Entropion
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Eye discharge
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0
Eye irritation
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0
Eye pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	2 / 50 (4.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	3	1	0	1	0	0	0	0	0	0	1	0	0	0	0	1	0
Eye pruritus
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Eyelid function disorder
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Eyelid pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Eyelid ptosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Growth of eyelashes
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	6 / 50 (12.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	2 / 14 (14.29%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	6	0	0	1	1	0	0	0	0	0	0	0	2	0	0	0	0
Iridocyclitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Keratitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0
Keratopathy
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Lacrimation decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Lacrimation increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	1 / 9 (11.11%)	1 / 7 (14.29%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	2	0	0	0	0	0	0	0	0	2	1	1	1	0
Macular fibrosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Meibomian gland dysfunction
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	2 / 50 (4.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	1 / 30 (3.33%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	2	0	1	1	0	1	0	0	0	0	0	0	0	0	0	0	0
Ocular discomfort
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Ocular hyperaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	1 / 6 (16.67%)	1 / 14 (7.14%)	3 / 30 (10.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	1	1	3	1	0	1	0	0	1	0	0	1	0	0	0	0
Ocular hypertension
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Ocular surface disease
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0
Periorbital oedema
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Photophobia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0
Photopsia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Pterygium
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Punctate keratitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	2	1	0	0	0	0	0	0	0	0	0	0	0	0
Retinal degeneration
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Retinal detachment
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Retinal disorder
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (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
Retinal fovea disorder
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (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
Retinal oedema
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0
Scleral discolouration
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Scleral hyperaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Subretinal fluid
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	2 / 9 (22.22%)	0 / 2 (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
Trichiasis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	6 / 30 (20.00%)	1 / 15 (6.67%)	2 / 4 (50.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	6	1	2	0	0	0	0	0	0	1	0	1	0	0
Ulcerative keratitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0
Vision blurred
subjects affected / exposed	1 / 3 (33.33%)	1 / 4 (25.00%)	2 / 7 (28.57%)	4 / 50 (8.00%)	2 / 6 (33.33%)	0 / 14 (0.00%)	5 / 30 (16.67%)	3 / 15 (20.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	1 / 6 (16.67%)	2 / 7 (28.57%)	0 / 3 (0.00%)	3 / 14 (21.43%)	1 / 9 (11.11%)	0 / 7 (0.00%)	3 / 9 (33.33%)	0 / 2 (0.00%)
occurrences all number	1	1	2	4	2	0	5	5	0	0	0	1	1	2	0	3	1	0	3	0
Visual acuity reduced
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	1 / 30 (3.33%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	1	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0
Visual impairment
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	2 / 14 (14.29%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	2	0	0	0	0
Vitreoretinal traction syndrome
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (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
Vitreous detachment
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0
Vitreous floaters
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	3 / 9 (33.33%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1	3	0
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Abdominal distension
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	4 / 50 (8.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	2 / 30 (6.67%)	3 / 15 (20.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	4	0	1	2	3	0	0	0	0	0	0	0	1	0	0	1	0
Abdominal pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	10 / 50 (20.00%)	1 / 6 (16.67%)	2 / 14 (14.29%)	6 / 30 (20.00%)	2 / 15 (13.33%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 1 (100.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	2 / 14 (14.29%)	2 / 9 (22.22%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	1	10	1	2	6	2	0	0	1	1	0	1	0	7	2	0	1	0
Abdominal pain lower
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 2 (50.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1
Abdominal pain upper
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	1 / 6 (16.67%)	2 / 14 (14.29%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	1	2	0	1	0	0	0	1	0	0	0	0	0	2	0	0
Abdominal tenderness
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Angular cheilitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Ascites
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	4 / 50 (8.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 30 (0.00%)	2 / 15 (13.33%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	4	1	0	0	3	0	0	0	0	0	0	1	0	0	2	1	0
Chapped lips
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Colitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Constipation
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	2 / 7 (28.57%)	14 / 50 (28.00%)	2 / 6 (33.33%)	4 / 14 (28.57%)	12 / 30 (40.00%)	4 / 15 (26.67%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	4 / 7 (57.14%)	2 / 6 (33.33%)	3 / 7 (42.86%)	0 / 3 (0.00%)	5 / 14 (35.71%)	1 / 9 (11.11%)	1 / 7 (14.29%)	3 / 9 (33.33%)	0 / 2 (0.00%)
occurrences all number	0	0	2	14	2	4	13	6	2	0	0	4	2	4	0	7	1	1	4	0
Diarrhoea
subjects affected / exposed	0 / 3 (0.00%)	1 / 4 (25.00%)	1 / 7 (14.29%)	12 / 50 (24.00%)	2 / 6 (33.33%)	3 / 14 (21.43%)	15 / 30 (50.00%)	9 / 15 (60.00%)	1 / 4 (25.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	4 / 7 (57.14%)	3 / 6 (50.00%)	6 / 7 (85.71%)	1 / 3 (33.33%)	7 / 14 (50.00%)	3 / 9 (33.33%)	3 / 7 (42.86%)	3 / 9 (33.33%)	1 / 2 (50.00%)
occurrences all number	0	1	3	12	2	3	18	12	2	2	0	7	3	13	1	17	7	6	6	1
Diarrhoea haemorrhagic
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Dry mouth
subjects affected / exposed	0 / 3 (0.00%)	1 / 4 (25.00%)	3 / 7 (42.86%)	17 / 50 (34.00%)	2 / 6 (33.33%)	5 / 14 (35.71%)	13 / 30 (43.33%)	8 / 15 (53.33%)	2 / 4 (50.00%)	3 / 3 (100.00%)	1 / 1 (100.00%)	2 / 7 (28.57%)	4 / 6 (66.67%)	1 / 7 (14.29%)	0 / 3 (0.00%)	4 / 14 (28.57%)	5 / 9 (55.56%)	4 / 7 (57.14%)	3 / 9 (33.33%)	2 / 2 (100.00%)
occurrences all number	0	1	5	19	2	5	13	8	2	3	1	2	4	1	0	5	5	4	3	2
Dyspepsia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	2 / 50 (4.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	5 / 30 (16.67%)	0 / 15 (0.00%)	1 / 4 (25.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	1 / 7 (14.29%)	2 / 6 (33.33%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	1	2	0	0	5	0	1	1	0	1	2	1	0	0	0	1	1	0
Dysphagia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	2 / 6 (33.33%)	0 / 14 (0.00%)	2 / 30 (6.67%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	3 / 14 (21.43%)	1 / 9 (11.11%)	3 / 7 (42.86%)	1 / 9 (11.11%)	1 / 2 (50.00%)
occurrences all number	0	0	0	1	2	0	3	0	0	0	0	0	0	0	0	3	1	4	1	1
Eructation
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (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
Flatulence
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	1 / 4 (25.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	1	0	0	0	1	0	0	0	1	1	0
Gastrointestinal haemorrhage
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	2 / 50 (4.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	1 / 30 (3.33%)	3 / 15 (20.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	2 / 7 (28.57%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	2	0	1	1	3	1	0	0	2	0	0	0	0	1	0	0	0
Gingival pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (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
Glossodynia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Haematochezia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0
Haemorrhoidal haemorrhage
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Haemorrhoids
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hiatus hernia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Hyperaesthesia teeth
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Hypoaesthesia oral
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Lip ulceration
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	1 / 30 (3.33%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	1	2	0	0	0	0	0	0	0	0	1	0	0	0
Loose tooth
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Mouth ulceration
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	1 / 30 (3.33%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	1	1	0	0	0	1	0	0	0	0	1	0	0	0
Nausea
subjects affected / exposed	1 / 3 (33.33%)	1 / 4 (25.00%)	1 / 7 (14.29%)	8 / 50 (16.00%)	2 / 6 (33.33%)	6 / 14 (42.86%)	13 / 30 (43.33%)	5 / 15 (33.33%)	3 / 4 (75.00%)	0 / 3 (0.00%)	1 / 1 (100.00%)	4 / 7 (57.14%)	2 / 6 (33.33%)	4 / 7 (57.14%)	0 / 3 (0.00%)	3 / 14 (21.43%)	3 / 9 (33.33%)	2 / 7 (28.57%)	3 / 9 (33.33%)	0 / 2 (0.00%)
occurrences all number	1	1	1	8	2	6	15	5	3	0	1	4	2	6	0	8	3	4	3	0
Oesophageal hypomotility
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Oesophageal stenosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Oesophageal ulcer
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (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
Oral dysaesthesia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	1 / 4 (25.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	1	0
Oral pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	3 / 50 (6.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	7 / 30 (23.33%)	2 / 15 (13.33%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	4	0	1	8	2	0	0	0	0	0	1	0	0	0	1	0	0
Paraesthesia oral
subjects affected / exposed	0 / 3 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Rectal haemorrhage
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Rectal tenesmus
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Stomatitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	2 / 7 (28.57%)	11 / 50 (22.00%)	3 / 6 (50.00%)	6 / 14 (42.86%)	15 / 30 (50.00%)	7 / 15 (46.67%)	2 / 4 (50.00%)	3 / 3 (100.00%)	1 / 1 (100.00%)	2 / 7 (28.57%)	2 / 6 (33.33%)	2 / 7 (28.57%)	1 / 3 (33.33%)	5 / 14 (35.71%)	3 / 9 (33.33%)	4 / 7 (57.14%)	7 / 9 (77.78%)	1 / 2 (50.00%)
occurrences all number	0	0	2	13	3	8	18	11	2	5	1	2	2	2	1	7	4	5	10	1
Tongue erythema
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Tooth disorder
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Vomiting
subjects affected / exposed	1 / 3 (33.33%)	0 / 4 (0.00%)	1 / 7 (14.29%)	7 / 50 (14.00%)	1 / 6 (16.67%)	4 / 14 (28.57%)	9 / 30 (30.00%)	3 / 15 (20.00%)	2 / 4 (50.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	3 / 7 (42.86%)	0 / 6 (0.00%)	3 / 7 (42.86%)	1 / 3 (33.33%)	3 / 14 (21.43%)	3 / 9 (33.33%)	2 / 7 (28.57%)	1 / 9 (11.11%)	1 / 2 (50.00%)
occurrences all number	2	0	1	7	1	4	12	6	4	0	0	5	0	5	1	5	3	4	1	1
Hepatobiliary disorders
Hyperbilirubinaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	3	0	0	0	0	0	0	0	0	0	0	0	0	0
Portal vein thrombosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Skin and subcutaneous tissue disorders
Actinic keratosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Alopecia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	3 / 7 (42.86%)	15 / 50 (30.00%)	1 / 6 (16.67%)	6 / 14 (42.86%)	11 / 30 (36.67%)	5 / 15 (33.33%)	1 / 4 (25.00%)	2 / 3 (66.67%)	0 / 1 (0.00%)	1 / 7 (14.29%)	5 / 6 (83.33%)	3 / 7 (42.86%)	0 / 3 (0.00%)	6 / 14 (42.86%)	5 / 9 (55.56%)	1 / 7 (14.29%)	3 / 9 (33.33%)	2 / 2 (100.00%)
occurrences all number	0	0	3	15	1	7	12	5	1	2	0	1	5	4	0	6	5	1	3	2
Decubitus ulcer
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 2 (50.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	1
Dry skin
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	5 / 50 (10.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	7 / 30 (23.33%)	1 / 15 (6.67%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	1 / 9 (11.11%)	0 / 7 (0.00%)	2 / 9 (22.22%)	0 / 2 (0.00%)
occurrences all number	0	0	0	5	0	0	7	1	1	0	0	0	1	1	0	0	1	0	2	0
Ecchymosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Eczema
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Eczema asteatotic
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Erythema
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	1	0	0	0
Hyperhidrosis
subjects affected / exposed	0 / 3 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	1	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0
Hyperkeratosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	2 / 30 (6.67%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	2	1	0	0	0	0	0	1	0	0	0	0	0	0
Hypertrichosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	2	1	0	0	0	0	0	0	0	0	0	0	0	0
Lichenoid keratosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Madarosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (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
Nail bed bleeding
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Nail bed tenderness
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	2 / 9 (22.22%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	2	0	0	0
Nail discolouration
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	5 / 50 (10.00%)	0 / 6 (0.00%)	2 / 14 (14.29%)	7 / 30 (23.33%)	3 / 15 (20.00%)	1 / 4 (25.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	1	5	0	2	7	3	1	1	0	0	0	1	0	0	1	0	0	0
Nail hypertrophy
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	1	0	0	0	0
Nail ridging
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	1 / 9 (11.11%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	1	0	1	0
Onychoclasis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Onycholysis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	5 / 50 (10.00%)	0 / 6 (0.00%)	2 / 14 (14.29%)	9 / 30 (30.00%)	3 / 15 (20.00%)	1 / 4 (25.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	1 / 14 (7.14%)	2 / 9 (22.22%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	5	0	2	11	3	1	1	0	0	0	1	0	1	3	0	1	0
Onychomadesis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	6 / 30 (20.00%)	0 / 15 (0.00%)	2 / 4 (50.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	1 / 9 (11.11%)	0 / 7 (0.00%)	2 / 9 (22.22%)	0 / 2 (0.00%)
occurrences all number	0	0	0	2	0	1	7	0	3	0	0	0	0	0	0	1	1	0	2	0
Pain of skin
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	1 / 6 (16.67%)	1 / 14 (7.14%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 2 (50.00%)
occurrences all number	0	0	0	0	1	1	1	0	0	0	0	0	0	0	0	1	0	0	0	1
Palmar-plantar erythrodysaesthesia syndrome
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 50 (0.00%)	1 / 6 (16.67%)	1 / 14 (7.14%)	8 / 30 (26.67%)	3 / 15 (20.00%)	2 / 4 (50.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	2 / 14 (14.29%)	1 / 9 (11.11%)	0 / 7 (0.00%)	2 / 9 (22.22%)	0 / 2 (0.00%)
occurrences all number	0	0	4	0	1	1	9	5	2	0	0	0	1	0	0	2	3	0	3	0
Paraneoplastic pemphigus
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Pruritus
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	3 / 30 (10.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	1	1	0	0	3	0	0	0	0	0	1	0	0	1	0	0	1	0
Psoriasis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Rash
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	5 / 30 (16.67%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	3 / 14 (21.43%)	1 / 9 (11.11%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	2	0	8	0	0	0	0	0	0	0	0	3	1	0	1	0
Rash maculo-papular
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0
Rash papular
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Rash pruritic
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0
Skin fissures
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0
Skin induration
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Skin irritation
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Skin lesion
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Skin ulcer
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (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
Urticaria
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Vitiligo
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	3 / 30 (10.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	1	3	1	0	0	0	1	0	0	0	0	0	0	0	0
Autoimmune nephritis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 2 (50.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Bladder pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Bladder spasm
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Dysuria
subjects affected / exposed	0 / 3 (0.00%)	1 / 4 (25.00%)	1 / 7 (14.29%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	0 / 15 (0.00%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	1	1	0	0	0	4	0	0	1	0	0	0	1	0	0	0	0	0	0
Haematuria
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Hydronephrosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0	0	0	0	0	1	0	0	0	1	0	0
Lower urinary tract symptoms
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Micturition urgency
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	2	0	0	0	0	0	0	0	0	1	0	0	1	0
Nephrolithiasis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (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
Nocturia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0
Pollakiuria
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (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
Urinary retention
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	2 / 7 (28.57%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	2	0	0	1	0	0	2	0	0	0	1	0	0	1	0
Urinary tract obstruction
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0
Urinary tract pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0
Endocrine disorders
Adrenal insufficiency
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Hyperparathyroidism
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	3 / 30 (10.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	2 / 14 (14.29%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	1	1	0	0	3	0	0	0	0	0	0	0	0	2	0	0	0	0
Hyperparathyroidism secondary
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Hyperthyroidism
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (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
Hypoparathyroidism
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	1	1	0	0	0
Hypothyroidism
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	2 / 50 (4.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	2	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0
Steroid withdrawal syndrome
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (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
Thyroiditis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 3 (0.00%)	1 / 4 (25.00%)	1 / 7 (14.29%)	4 / 50 (8.00%)	2 / 6 (33.33%)	4 / 14 (28.57%)	4 / 30 (13.33%)	1 / 15 (6.67%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	1 / 3 (33.33%)	4 / 14 (28.57%)	2 / 9 (22.22%)	0 / 7 (0.00%)	2 / 9 (22.22%)	1 / 2 (50.00%)
occurrences all number	0	1	1	4	2	5	6	1	0	2	0	0	0	1	1	7	2	0	3	1
Arthritis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Back pain
subjects affected / exposed	1 / 3 (33.33%)	0 / 4 (0.00%)	2 / 7 (28.57%)	3 / 50 (6.00%)	0 / 6 (0.00%)	2 / 14 (14.29%)	3 / 30 (10.00%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	1 / 7 (14.29%)	1 / 3 (33.33%)	2 / 14 (14.29%)	1 / 9 (11.11%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	0	2	3	0	2	4	0	1	0	0	0	1	1	1	2	1	1	0	0
Bone pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (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
Flank pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	2 / 50 (4.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	2 / 15 (13.33%)	1 / 4 (25.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	1	2	0	0	2	2	1	1	0	0	0	0	0	0	0	0	0	0
Joint swelling
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0
Muscle spasms
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	1 / 7 (14.29%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	1	0	1	1	0
Muscle tightness
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Muscular weakness
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	2 / 9 (22.22%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	0	2	0
Musculoskeletal chest pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	1	1	0	0	1	0	0	0	0	1	0	0	0	1	0	0	0	0
Musculoskeletal pain
subjects affected / exposed	0 / 3 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	3	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Myalgia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	5 / 50 (10.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	5 / 30 (16.67%)	0 / 15 (0.00%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	5	0	0	5	0	0	1	0	0	1	0	0	1	1	0	0	0
Neck pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Osteoarthritis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Osteonecrosis of jaw
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (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
Pain in extremity
subjects affected / exposed	0 / 3 (0.00%)	1 / 4 (25.00%)	2 / 7 (28.57%)	3 / 50 (6.00%)	1 / 6 (16.67%)	3 / 14 (21.43%)	5 / 30 (16.67%)	3 / 15 (20.00%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 3 (33.33%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	1 / 2 (50.00%)
occurrences all number	0	2	2	3	1	3	6	3	0	1	0	1	0	0	1	1	0	0	1	1
Trismus
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Infections and infestations
Acute sinusitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0
Body tinea
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Bronchitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	1 / 9 (11.11%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	1	0	0	1	1	0	0	0	0	0	0	0	0	0	2	0	1	0
Candida infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	2	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Catheter site cellulitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Cellulitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	2 / 50 (4.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	1 / 30 (3.33%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	2	4	0	2	1	1	0	0	0	0	0	0	0	1	0	0	0	0
Conjunctivitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	2 / 9 (22.22%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	1	0	0	0	1	0	0	0	0	0	0	1	0	0	2	0	0	0
Diverticulitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Ear infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Eye infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Gastroenteritis viral
subjects affected / exposed	0 / 3 (0.00%)	1 / 4 (25.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Herpes ophthalmic
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Herpes simplex
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0
Influenza
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	3	0	0	0	0	0	0	0	0	0	0	0	0	0
Nail infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	3 / 30 (10.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	1	3	1	0	1	0	0	0	0	0	0	0	0	0	0
Nasopharyngitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Oral candidiasis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	1 / 30 (3.33%)	2 / 15 (13.33%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	2	2	0	0	0	0	0	0	0	2	0	3	0	0
Oral herpes
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	3	0	0	0	0	0	0	0	0	0	0	0	0	0
Paronychia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	2 / 50 (4.00%)	2 / 6 (33.33%)	2 / 14 (14.29%)	4 / 30 (13.33%)	2 / 15 (13.33%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	2 / 7 (28.57%)	0 / 3 (0.00%)	2 / 14 (14.29%)	1 / 9 (11.11%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	0	2	2	4	6	2	0	0	0	0	1	2	0	2	2	0	1	0
Pharyngitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Pneumonia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	1	0	0	0	0
Sinusitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	3 / 6 (50.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	1 / 2 (50.00%)
occurrences all number	0	0	0	1	0	1	3	0	0	0	0	0	3	1	0	0	0	0	1	1
Skin infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0
Tinea pedis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Tinea versicolour
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Tooth infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (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
Upper respiratory tract infection
subjects affected / exposed	1 / 3 (33.33%)	0 / 4 (0.00%)	0 / 7 (0.00%)	2 / 50 (4.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	4 / 30 (13.33%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	2 / 6 (33.33%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	1	0	0	2	0	0	4	1	0	0	0	0	2	0	0	1	0	1	0	0
Urinary tract infection
subjects affected / exposed	0 / 3 (0.00%)	1 / 4 (25.00%)	1 / 7 (14.29%)	1 / 50 (2.00%)	0 / 6 (0.00%)	2 / 14 (14.29%)	1 / 30 (3.33%)	5 / 15 (33.33%)	2 / 4 (50.00%)	1 / 3 (33.33%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	1 / 14 (7.14%)	3 / 9 (33.33%)	2 / 7 (28.57%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	2	1	1	0	3	1	5	2	1	0	0	0	2	0	1	5	4	0	0
Urinary tract infection bacterial
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Vaginal infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (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
Metabolism and nutrition disorders
Cachexia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Decreased appetite
subjects affected / exposed	0 / 3 (0.00%)	2 / 4 (50.00%)	1 / 7 (14.29%)	12 / 50 (24.00%)	1 / 6 (16.67%)	1 / 14 (7.14%)	11 / 30 (36.67%)	5 / 15 (33.33%)	2 / 4 (50.00%)	2 / 3 (66.67%)	0 / 1 (0.00%)	2 / 7 (28.57%)	3 / 6 (50.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	9 / 14 (64.29%)	2 / 9 (22.22%)	1 / 7 (14.29%)	3 / 9 (33.33%)	1 / 2 (50.00%)
occurrences all number	0	2	1	12	1	1	11	5	2	2	0	2	3	2	0	11	2	1	6	1
Dehydration
subjects affected / exposed	1 / 3 (33.33%)	1 / 4 (25.00%)	0 / 7 (0.00%)	6 / 50 (12.00%)	1 / 6 (16.67%)	1 / 14 (7.14%)	4 / 30 (13.33%)	4 / 15 (26.67%)	4 / 4 (100.00%)	1 / 3 (33.33%)	1 / 1 (100.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	4 / 7 (57.14%)	1 / 3 (33.33%)	2 / 14 (14.29%)	1 / 9 (11.11%)	3 / 7 (42.86%)	3 / 9 (33.33%)	1 / 2 (50.00%)
occurrences all number	1	1	0	7	2	1	4	4	6	1	1	1	0	7	1	3	1	3	6	1
Fluid overload
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (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
Fluid retention
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Glucose tolerance impaired
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Hypercalcaemia
subjects affected / exposed	1 / 3 (33.33%)	0 / 4 (0.00%)	1 / 7 (14.29%)	5 / 50 (10.00%)	0 / 6 (0.00%)	2 / 14 (14.29%)	8 / 30 (26.67%)	3 / 15 (20.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	1 / 3 (33.33%)	4 / 14 (28.57%)	0 / 9 (0.00%)	0 / 7 (0.00%)	2 / 9 (22.22%)	0 / 2 (0.00%)
occurrences all number	1	0	1	8	0	2	9	3	1	0	0	0	0	1	1	6	0	0	2	0
Hypercholesterolaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	1 / 14 (7.14%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	1	0	0	0	0
Hyperglycaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	2 / 50 (4.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	2 / 15 (13.33%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 7 (14.29%)	1 / 3 (33.33%)	3 / 14 (21.43%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	1	2	0	0	3	2	0	0	0	1	0	2	1	4	0	1	0	0
Hyperkalaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 30 (0.00%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	2 / 14 (14.29%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	1	0	1	0	0	0	2	0	2	0	2	1	0	0	0
Hyperphosphataemia
subjects affected / exposed	0 / 3 (0.00%)	1 / 4 (25.00%)	4 / 7 (57.14%)	39 / 50 (78.00%)	4 / 6 (66.67%)	8 / 14 (57.14%)	28 / 30 (93.33%)	13 / 15 (86.67%)	4 / 4 (100.00%)	3 / 3 (100.00%)	1 / 1 (100.00%)	3 / 7 (42.86%)	5 / 6 (83.33%)	6 / 7 (85.71%)	3 / 3 (100.00%)	11 / 14 (78.57%)	5 / 9 (55.56%)	4 / 7 (57.14%)	5 / 9 (55.56%)	2 / 2 (100.00%)
occurrences all number	0	2	13	78	6	12	49	19	5	5	1	6	9	7	4	41	7	4	9	4
Hypertriglyceridaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	1	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	1	0
Hyperuricaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	2 / 14 (14.29%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	1 / 2 (50.00%)
occurrences all number	0	0	1	1	0	0	3	1	0	0	0	1	0	0	0	4	0	0	0	1
Hypoalbuminaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	3 / 50 (6.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 30 (6.67%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 1 (100.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	1 / 7 (14.29%)	1 / 3 (33.33%)	2 / 14 (14.29%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	4	0	0	4	1	0	0	1	0	1	2	1	2	0	0	0	0
Hypocalcaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	2 / 14 (14.29%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	1	1	0	0	1	0	0	0	0	0	0	1	0	2	0	0	0	0
Hypoglycaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	1 / 50 (2.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 30 (3.33%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	1	0	0	1	0	0	0	0	0	0	3	0	0	0	0	0	0
Hypokalaemia
subjects affected / exposed	1 / 3 (33.33%)	1 / 4 (25.00%)	2 / 7 (28.57%)	3 / 50 (6.00%)	0 / 6 (0.00%)	2 / 14 (14.29%)	1 / 30 (3.33%)	2 / 15 (13.33%)	1 / 4 (25.00%)	1 / 3 (33.33%)	1 / 1 (100.00%)	2 / 7 (28.57%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	3 / 14 (21.43%)	0 / 9 (0.00%)	2 / 7 (28.57%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	1	1	2	3	0	2	1	3	1	2	2	3	0	0	0	4	0	2	1	0
Hypomagnesaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	2 / 50 (4.00%)	1 / 6 (16.67%)	2 / 14 (14.29%)	1 / 30 (3.33%)	1 / 15 (6.67%)	0 / 4 (0.00%)	1 / 3 (33.33%)	1 / 1 (100.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 7 (14.29%)	1 / 3 (33.33%)	5 / 14 (35.71%)	0 / 9 (0.00%)	3 / 7 (42.86%)	2 / 9 (22.22%)	1 / 2 (50.00%)
occurrences all number	0	0	1	3	1	2	1	1	0	1	1	1	0	1	1	5	0	3	2	1
Hyponatraemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	3 / 50 (6.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	8 / 30 (26.67%)	4 / 15 (26.67%)	0 / 4 (0.00%)	1 / 3 (33.33%)	1 / 1 (100.00%)	3 / 7 (42.86%)	0 / 6 (0.00%)	2 / 7 (28.57%)	1 / 3 (33.33%)	2 / 14 (14.29%)	1 / 9 (11.11%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	1	5	1	0	14	5	0	2	1	3	0	3	2	2	1	0	0	0
Hypophosphataemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	2 / 7 (28.57%)	10 / 50 (20.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	5 / 30 (16.67%)	2 / 15 (13.33%)	2 / 4 (50.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 3 (0.00%)	3 / 14 (21.43%)	1 / 9 (11.11%)	0 / 7 (0.00%)	1 / 9 (11.11%)	0 / 2 (0.00%)
occurrences all number	0	0	4	17	1	0	7	2	2	0	0	0	1	0	0	4	1	0	1	0
Malnutrition
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	1 / 7 (14.29%)	0 / 9 (0.00%)	0 / 2 (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
Metabolic acidosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	0 / 7 (0.00%)	0 / 50 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 30 (0.00%)	0 / 15 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 3 (0.00%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Vitamin D deficiency
subjects affected / exposed	0 / 3 (0.00%)	0 / 4 (0.00%)	1 / 7 (14.29%)	3 / 50 (6.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	4 / 30 (13.33%)	1 / 15 (6.67%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	2 / 3 (66.67%)	0 / 14 (0.00%)	0 / 9 (0.00%)	0 / 7 (0.00%)	0 / 9 (0.00%)	0 / 2 (0.00%)
occurrences all number	0	0	1	3	1	0	4	1	0	0	0	0	0	0	2	0	0	0	0	0

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

19 Nov 2014

The objective of this amendment was to address the Food and Drug Administration's (FDA's) November 17, 2014, clinical deficiencies.

11 Jun 2015

The objective of this amendment was to refine procedural language regarding pharmacokinetics (PK) and food effect, ophthalmologic examination frequency, electrocardiogram (ECG) monitoring, and biopsy requirements.

02 Nov 2015

The primary purpose of this amendment was to add Part 3, Combination Therapy. In Part 3, INCB054828 was paired with 3 different treatment regimens that were already being used for cancer treatment. The amendment also contained changes to the inclusion/exclusion criteria and corrections to the Schedule of Assessment tables.

09 Mar 2016

The primary purpose of this amendment was to adjust language in the protocol to allow more flexibility for enrollment based on accumulated safety data. The secondary purpose was to adjust the management guidelines for hyperphosphatemia (HP).

27 Sep 2016

The primary purpose of this amendment was to revise the study design in order to add a continuous dosing cohort, a trastuzumab combination cohort in Part 3, and a lower dose level cohort in Part 1 and Part 3 with mandatory biopsies, and to increase the number of participants in the study.

26 Jun 2017

The primary purpose of this amendment was to increase the number of participants in Part 2 and make changes to clarify and/or simplify the study design.

10 Aug 2018

The protocol was updated to include 1) a new combination treatment arm, 2) a renally impaired treatment arm, and 3) mandatory biopsies.

11 Dec 2018

Changes were made to the protocol based on FDA feedback after review of Amendment 7. Additional changes included the modification of ECG sampling times and the addition of a 4.5-milligram (mg) tablet across all sites/countries.

02 Jul 2019

The amendment added a twice daily (BID) dosing regimen and updated the clinical experience section.

27 Mar 2020

The amendment incorporated administrative changes and included updated language for comprehensive eye examination, per FDA feedback.

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.

None reported

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies (FIGHT-101)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Parts 1 and 2 Combined: Number of participants with any treatment-emergent adverse event (TEAE)

Primary: Parts 1 and 2 Combined: Number of participants with any treatment-emergent adverse event (TEAE)

Primary: Part 3: Number of participants with any TEAE

Primary: Part 3: Number of participants with any TEAE

Primary: E0 following once daily dosing of pemigatinib as monotherapy in Parts 1 and 2

Primary: E0 following once daily dosing of pemigatinib as monotherapy in Parts 1 and 2

Primary: EC50 following once daily dosing of pemigatinib as monotherapy in Parts 1 and 2

Primary: EC50 following once daily dosing of pemigatinib as monotherapy in Parts 1 and 2

Primary: Emax following once daily dosing of pemigatinib as monotherapy in Parts 1 and 2

Primary: Emax following once daily dosing of pemigatinib as monotherapy in Parts 1 and 2

Primary: Highest serum phosphate concentration following pemigatinib as monotherapy in Parts 1 and 2

Primary: Highest serum phosphate concentration following pemigatinib as monotherapy in Parts 1 and 2

Secondary: Part 2: Overall response rate (ORR)

Secondary: Part 2: Overall response rate (ORR)

Secondary: Part 3: ORR

Secondary: Part 3: ORR

Secondary: Parts 1 and 2: Cmax after once daily dosing of pemigatinib as monotherapy on Cycle 1 Day 1

Secondary: Parts 1 and 2: Cmax after once daily dosing of pemigatinib as monotherapy on Cycle 1 Day 1

Secondary: Parts 1 and 2: tmax after once daily dosing of pemigatinib as monotherapy on Cycle 1 Day 1

Secondary: Parts 1 and 2: tmax after once daily dosing of pemigatinib as monotherapy on Cycle 1 Day 1

Secondary: Parts 1 and 2: AUClast after once daily dosing of pemigatinib as monotherapy on Cycle 1 Day 1

Secondary: Parts 1 and 2: AUClast after once daily dosing of pemigatinib as monotherapy on Cycle 1 Day 1

Secondary: Parts 1 and 2: AUC0-24 after once daily dosing of pemigatinib as monotherapy on Cycle 1 Day 1

Secondary: Parts 1 and 2: AUC0-24 after once daily dosing of pemigatinib as monotherapy on Cycle 1 Day 1

Secondary: Parts 1 and 2: Cmax after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Secondary: Parts 1 and 2: Cmax after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Secondary: Parts 1 and 2: tmax after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Secondary: Parts 1 and 2: tmax after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Secondary: Parts 1 and 2: t1/2 after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Secondary: Parts 1 and 2: t1/2 after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Secondary: Parts 1 and 2: Cmin after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Secondary: Parts 1 and 2: Cmin after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Secondary: Parts 1 and 2: AUC0-24 after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Secondary: Parts 1 and 2: AUC0-24 after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Secondary: Parts 1 and 2: CL/F after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Secondary: Parts 1 and 2: CL/F after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Secondary: Parts 1 and 2: Vz/F after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Secondary: Parts 1 and 2: Vz/F after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Secondary: Parts 1 and 2: Accumulation ratio after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Secondary: Parts 1 and 2: Accumulation ratio after once daily dosing of pemigatinib as monotherapy on Cycle 1 Days 8 and 14 (steady state)

Secondary: Parts 1 and 2: Cmax steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

Secondary: Parts 1 and 2: Cmax steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

Secondary: Parts 1 and 2: tmax steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

Secondary: Parts 1 and 2: tmax steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

Secondary: Parts 1 and 2: t1/2 steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

Secondary: Parts 1 and 2: t1/2 steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

Secondary: Parts 1 and 2: Cmin steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

Secondary: Parts 1 and 2: Cmin steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

Secondary: Parts 1 and 2: AUC0-24 steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

Secondary: Parts 1 and 2: AUC0-24 steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

Secondary: Parts 1 and 2: CL/F steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

Secondary: Parts 1 and 2: CL/F steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

Secondary: Parts 1 and 2: Vz/F steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

Secondary: Parts 1 and 2: Vz/F steady state following administration of pemigatinib in the fasted (Cycle 1 Day 14) and fed (Cycle 2 Day 14) states

Secondary: Part 3: Cmax of pemigatinib as part of combination therapy on Cycle 1 Day 1

Secondary: Part 3: Cmax of pemigatinib as part of combination therapy on Cycle 1 Day 1

Secondary: Part 3: tmax of pemigatinib as part of combination therapy on Cycle 1 Day 1

Secondary: Part 3: tmax of pemigatinib as part of combination therapy on Cycle 1 Day 1

Secondary: Part 3: AUClast of pemigatinib as part of combination therapy on Cycle 1 Day 1

Secondary: Part 3: AUClast of pemigatinib as part of combination therapy on Cycle 1 Day 1

Secondary: Part 3: AUC0-24 of pemigatinib as part of combination therapy on Cycle 1 Day 1

Secondary: Part 3: AUC0-24 of pemigatinib as part of combination therapy on Cycle 1 Day 1

Secondary: Part 3: Cmax of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state)

Secondary: Part 3: Cmax of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state)

Secondary: Part 3: tmax of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state)

Secondary: Part 3: tmax of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state)

Secondary: Part 3: t1/2 of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state)

Secondary: Part 3: t1/2 of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state)

Secondary: Part 3: Cmin of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state)

Secondary: Part 3: Cmin of pemigatinib as part of combination therapy on Cycle 1 Day 14 (steady state)

Clinical Trial Results:
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies (FIGHT-101)