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Clinical Trial Results:
A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination With Azacitidine or Cytarabine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation

Summary
EudraCT number	2017-001051-32
Trial protocol	DE ES GB IT
Global end of trial date	24 Jan 2024

Results information
Results version number	v1(current)
This version publication date	10 May 2025
First version publication date	10 May 2025
Other versions

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

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Trial information

Top of page

Sponsor protocol code

2102-HEM-101

ISRCTN number

US NCT number

NCT02719574

WHO universal trial number (UTN)

Sponsor organisation name

Novo Nordisk A/S

Sponsor organisation address

Novo Alle, Bagsvaerd, Denmark, 2880

Public contact

Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.com

Scientific contact

Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.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

20 Dec 2023

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

24 Jan 2024

Was the trial ended prematurely?

Main objective of the trial

Phase 1: To determine the MTDs, the MEDs, dose-limiting toxicities (DLTs), and the RP2Ds of FT-2102 as a single agent, in combination with azacitidine, and in combination with cytarabine in patients with AML or MDS harboring an IDH1-R132 mutation Phase 2: To evaluate the antileukemic and anti myelodysplastic activity of FT-2102 as a single agent or in combination with azacitidine in patients with AML or MDS, respec-tively harboring an IDH1-R132 mutation.

Protection of trial subjects

The trial was conducted in accordance with the Declaration of Helsinki (Oct 2013) and ICH Good Clinical Practice, including archiving of essential documents (May 1996) and EN ISO 14155 Part 1 and 2 and FDA 21 CFR 312.120.

Background therapy

Evidence for comparator

Actual start date of recruitment

22 Aug 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 13

Country: Number of subjects enrolled

Australia: 37

Country: Number of subjects enrolled

France: 96

Country: Number of subjects enrolled

Germany: 7

Country: Number of subjects enrolled

Italy: 17

Country: Number of subjects enrolled

Korea, Republic of: 3

Country: Number of subjects enrolled

Spain: 30

Country: Number of subjects enrolled

United Kingdom: 17

Country: Number of subjects enrolled

United States: 116

Worldwide total number of subjects

336

EEA total number of subjects

150

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)

From 65 to 84 years

240

85 years and over

Subject disposition

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Recruitment details

Total 336 subjects enrolled in the study. In phase l, 78 subjects were enrolled in single cohorts (FT-2102) and combination cohorts (FT-2102 with azacitidine/cytarabine) and in phase 2, 258 subjects were enrolled in single cohorts (FT-2102) and combination cohorts (FT-2102 with azacitidine).

Screening details

This study is comprised of 3 stages: Phase 1 dose-escalation stage, Phase 1 dose-expansion stage, and Phase 2 stage. Subjects with R/R AML or MDS with IDH1-R132 mutations received FT-2102 alone or with azacitidine/ cytarabine in Phase 1 and 2. Based on totality of data from Phase 1, RP2D for single-agent and combination treatment was determined.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Phase 1: Total FT-2102 (Single Agent)

Arm description

Subjects with AML or MDS received single agent Olutasidenib (FT-2102) orally once daily (QD) and BID in 28-day cycles at the different dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.

Arm type

Experimental

Investigational medicinal product name

FT-2102

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Subjects with AML or MDS received single agent of FT-2102 150 mg BID in continuous 28-day cycles.

Phase1:TotalFT-2102;FT-2102+azacitidine(Combination Therapy)

Arm description

Subjects with AML or MDS received combination therapy azacitidine (administered at the dose of 75 mg/m^2 for 7 days IV/SC +FT-2102 150 mg BID per every 28-day cycle) until treatment discontinuation.

Arm type

Experimental

Investigational medicinal product name

FT- 2102+azacitidine

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection, Capsule, hard

Routes of administration

Subcutaneous use, Intravenous use, Oral use

Dosage and administration details

Subjects with AML or MDS received combination therapy azacitidine (administered at the dose of 75 mg/m^2 for 7 days IV/SC per every 28-day cycle +FT-2102 150 mg BID ) until treatment discontinuation.

Phase 1: FT-2102 +Cytarabine (Combination Therapy)

Arm description

Subjects with AML harboring IDH1 mutation received FT-2102 in combination with low-dose cytarabine (LDAC) administered at the dose of 20 mg BID SC for 10 days every 28-day cycle until treatment discontinuation.

Arm type

Experimental

Investigational medicinal product name

FT-2102+cytarabine

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection, Capsule, hard

Routes of administration

Subcutaneous use, Oral use

Dosage and administration details

Subjects with AML harboring IDH1 mutation received FT-2102 in combination with LDAC administered at the dose of 20 mg BID SC for 10 days every 28-day.

Phase 2: Cohort 1; FT-2102 (Single Agent)

Arm description

Subjects with relapsed/refractory (R/R) AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.

Arm type

Experimental

Investigational medicinal product name

FT-2102

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Subjects with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.

Phase 2: Cohort 2; FT-2102 (Single Agent)

Arm description

Subjects with AML in morphologic complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) after prior therapy with residual isocitrate dehydrogenase 1 ([IDH1]-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.

Arm type

Experimental

Investigational medicinal product name

FT-2102

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Subjects with AML in morphologic CR/CRi after prior therapy with residual IDH1-R132 mutation received single agent of FT-2102 150 mg BID in continuous 28-day cycles.

Phase 2: Cohort 3; FT-2102 (Single Agent)

Arm description

Subjects with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.

Arm type

Experimental

Investigational medicinal product name

FT-2102

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Subjects with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCTreceived single agent of FT-2102 150 mg BID in continuous 28-day cycles.

Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)

Arm description

Subjects with relapsed/refractory (R/R) AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.

Arm type

Experimental

Investigational medicinal product name

FT-2102+azacitidine

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection, Capsule, hard

Routes of administration

Subcutaneous use, Oral use, Intravenous use

Dosage and administration details

Subjects with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine+ FT-2102 150 mg BID in continuous 28-day cycles.

Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)

Arm description

Subjects with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.

Arm type

Experimental

Investigational medicinal product name

FT-2102+azacitidine

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection, Capsule, hard

Routes of administration

Subcutaneous use, Oral use, Intravenous use

Dosage and administration details

Subjects with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles.

Phase 2: Cohort 6; FT-2102+azacitidine (Combination Therapy)

Arm description

Subjects with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in con-tinuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.

Arm type

Experimental

Investigational medicinal product name

FT-2102+azacitidine

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection, Capsule, hard

Routes of administration

Subcutaneous use, Oral use, Intravenous use

Dosage and administration details

Phase 2: Cohort 7; FT-2102 (Single Agent)

Arm description

Subjects who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given single agent of FT-2102 150 mg BID in continuous 28-day cycles.

Arm type

Experimental

Investigational medicinal product name

FT-2102

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Phase 2: Cohort 8; FT-2102+azacitidine (Combination Therapy)

Arm description

Subjects who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine 75 mg/m^2 + FT-2102 150 mg BID in continuous 28-day cycles.

Arm type

Experimental

Investigational medicinal product name

FT-2102+azacitidine

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection, Capsule, hard

Routes of administration

Subcutaneous use, Oral use, Intravenous use

Dosage and administration details

Subjects who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy be given combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles.

Number of subjects in period 1	Phase 1: Total FT-2102 (Single Agent)	Phase1:TotalFT-2102;FT-2102+azacitidine(Combination Therapy)	Phase 1: FT-2102 +Cytarabine (Combination Therapy)	Phase 2: Cohort 1; FT-2102 (Single Agent)	Phase 2: Cohort 2; FT-2102 (Single Agent)	Phase 2: Cohort 3; FT-2102 (Single Agent)	Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 6; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 7; FT-2102 (Single Agent)	Phase 2: Cohort 8; FT-2102+azacitidine (Combination Therapy)
Started	31	46	1	153	18	5	20	21	20	10	11
Completed	0	0	0	0	0	0	0	0	0	0	0
Not completed	31	46	1	153	18	5	20	21	20	10	11
Adverse event, serious fatal	5	6	-	14	-	-	1	1	2	-	-
Protocol Defined Disease Progression	11	14	1	65	8	2	4	9	11	3	4
Consent withdrawn by subject	1	-	-	5	-	-	-	1	1	2	-
Adverse event, non-fatal	3	3	-	27	-	1	1	1	2	2	3
Unknown	6	9	-	20	7	-	5	7	-	1	4
Investigator Decision	1	5	-	6	1	2	3	1	3	2	-
Transplant	4	9	-	15	2	-	6	1	1	-	-
Protocol deviation	-	-	-	1	-	-	-	-	-	-	-

Baseline characteristics

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Reporting group title

Phase 1: Total FT-2102 (Single Agent)

Reporting group description

Subjects with AML or MDS received single agent Olutasidenib (FT-2102) orally once daily (QD) and BID in 28-day cycles at the different dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.

Reporting group title

Phase1:TotalFT-2102;FT-2102+azacitidine(Combination Therapy)

Reporting group description

Subjects with AML or MDS received combination therapy azacitidine (administered at the dose of 75 mg/m^2 for 7 days IV/SC +FT-2102 150 mg BID per every 28-day cycle) until treatment discontinuation.

Reporting group title

Phase 1: FT-2102 +Cytarabine (Combination Therapy)

Reporting group description

Reporting group title

Phase 2: Cohort 1; FT-2102 (Single Agent)

Reporting group description

Subjects with relapsed/refractory (R/R) AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.

Reporting group title

Phase 2: Cohort 2; FT-2102 (Single Agent)

Reporting group description

Reporting group title

Phase 2: Cohort 3; FT-2102 (Single Agent)

Reporting group description

Subjects with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.

Reporting group title

Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)

Reporting group description

Reporting group title

Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)

Reporting group description

Reporting group title

Phase 2: Cohort 6; FT-2102+azacitidine (Combination Therapy)

Reporting group description

Reporting group title

Phase 2: Cohort 7; FT-2102 (Single Agent)

Reporting group description

Reporting group title

Phase 2: Cohort 8; FT-2102+azacitidine (Combination Therapy)

Reporting group description

Reporting group values	Phase 1: Total FT-2102 (Single Agent)	Phase1:TotalFT-2102;FT-2102+azacitidine(Combination Therapy)	Phase 1: FT-2102 +Cytarabine (Combination Therapy)	Phase 2: Cohort 1; FT-2102 (Single Agent)	Phase 2: Cohort 2; FT-2102 (Single Agent)	Phase 2: Cohort 3; FT-2102 (Single Agent)	Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 6; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 7; FT-2102 (Single Agent)	Phase 2: Cohort 8; FT-2102+azacitidine (Combination Therapy)	Total
Number of subjects	31	46	1	153	18	5	20	21	20	10	11	336
Age Categorical
Units: subjects
<65	7	16	0	37	5	1	16	3	3	0	1	89
65 - <75	13	20	0	68	11	3	2	9	9	3	6	144
>=75	11	10	1	48	2	1	2	9	8	7	4	103
Sex: Female, Male
Units: subjects
Female	16	24	0	74	6	2	11	7	10	6	2	158
Male	15	22	1	79	12	3	9	14	10	4	9	178

Subject analysis set title

Phase 1: Overall

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent (FT-2102), combination therapy (FT-2102 + azacitidine, FT-2102+ LDAC) starting at 150 mg BID dose level until MTD or MED achieved or treatment discontinuation.

Subject analysis set title

Phase 2: Single Agent Overall

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with R/R AML, AML in morphologic complete remission (CR)/ complete remission with incomplete blood CRi after prior therapy with residual isocitrate dehydrogenase 1 ([IDH1]-R132 mutation, who underwent HSCT on-study then relapsed post-HSCT, have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy received single agent of FT-2102 150 mg BID in continuous 28-day cycles.

Subject analysis set title

Phase 2: Combination Therapy

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy, with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy, R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment and who have not received any prior AML treatment but may have received a prior treatment for another hematologic malignancy received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles until disease progression.

Subject analysis set title

Phase 1: FT-2102 (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: Total FT-2102 (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the different dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 + azacitidine (Combination Therapy)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: Total FT-2102 (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the different dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 + azacitidine (Combination Therapy)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 100 mg QD (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose level of 100 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 150 mg QD (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 300 mg QD (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose levels of 300 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 150 mg BID (Single Agent

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 150 mg QD+azacitidine(Combination Therapy)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally QD in 28-day cycles at dose levels of 150 mg until MTD or MED achieved

Subject analysis set title

Phase 1: FT-2102 150 mg BID+azacitidine(Combination Therapy)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase: FT-2102 150 mg BID (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 150 mg BID+azacitidine(Combination Therapy)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 150 mg BID (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: Total FT-2102 (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the different dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102+azacitidine (Combination Therapy)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with acute AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: Total FT-2102 (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the different dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102+azacitidine (Combination Therapy)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis sets values	Phase 1: Overall	Phase 2: Single Agent Overall	Phase 2: Combination Therapy	Phase 1: FT-2102 (Single Agent)	Phase 1: Total FT-2102 (Single Agent)	Phase 1: FT-2102 + azacitidine (Combination Therapy)	Phase 1: FT-2102 (Single Agent)	Phase 1: Total FT-2102 (Single Agent)	Phase 1: FT-2102 + azacitidine (Combination Therapy)	Phase 1: FT-2102 100 mg QD (Single Agent)	Phase 1: FT-2102 150 mg QD (Single Agent)	Phase 1: FT-2102 300 mg QD (Single Agent)	Phase 1: FT-2102 150 mg BID (Single Agent	Phase 1: FT-2102 150 mg QD+azacitidine(Combination Therapy)	Phase 1: FT-2102 150 mg BID+azacitidine(Combination Therapy)	Phase: FT-2102 150 mg BID (Single Agent)	Phase 1: FT-2102 150 mg BID+azacitidine(Combination Therapy)	Phase 1: FT-2102 150 mg BID (Single Agent)	Phase 1: FT-2102 (Single Agent)	Phase 1: Total FT-2102 (Single Agent)	Phase 1: FT-2102+azacitidine (Combination Therapy)	Phase 1: FT-2102 (Single Agent)	Phase 1: Total FT-2102 (Single Agent)	Phase 1: FT-2102+azacitidine (Combination Therapy)
Number of subjects	78	186	72	16	31	39	15	30	38	3	8	4	6	7	8	6	8	6	5	10	18	2	2	6
Age Categorical
Units: subjects
<65
65 - <75
>=75
Age continuous
Units:
	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )
Sex: Female, Male
Units: subjects
Female	40	88	30
Male	38	98	42

End points

Top of page

Reporting group title

Phase 1: Total FT-2102 (Single Agent)

Reporting group description

Subjects with AML or MDS received single agent Olutasidenib (FT-2102) orally once daily (QD) and BID in 28-day cycles at the different dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.

Reporting group title

Phase1:TotalFT-2102;FT-2102+azacitidine(Combination Therapy)

Reporting group description

Subjects with AML or MDS received combination therapy azacitidine (administered at the dose of 75 mg/m^2 for 7 days IV/SC +FT-2102 150 mg BID per every 28-day cycle) until treatment discontinuation.

Reporting group title

Phase 1: FT-2102 +Cytarabine (Combination Therapy)

Reporting group description

Reporting group title

Phase 2: Cohort 1; FT-2102 (Single Agent)

Reporting group description

Subjects with relapsed/refractory (R/R) AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.

Reporting group title

Phase 2: Cohort 2; FT-2102 (Single Agent)

Reporting group description

Reporting group title

Phase 2: Cohort 3; FT-2102 (Single Agent)

Reporting group description

Subjects with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.

Reporting group title

Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)

Reporting group description

Reporting group title

Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)

Reporting group description

Reporting group title

Phase 2: Cohort 6; FT-2102+azacitidine (Combination Therapy)

Reporting group description

Reporting group title

Phase 2: Cohort 7; FT-2102 (Single Agent)

Reporting group description

Reporting group title

Phase 2: Cohort 8; FT-2102+azacitidine (Combination Therapy)

Reporting group description

Subject analysis set title

Phase 1: Overall

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Phase 2: Single Agent Overall

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Phase 2: Combination Therapy

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Phase 1: FT-2102 (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: Total FT-2102 (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the different dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 + azacitidine (Combination Therapy)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: Total FT-2102 (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the different dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 + azacitidine (Combination Therapy)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 100 mg QD (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose level of 100 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 150 mg QD (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 300 mg QD (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally QD in 28-day cycles at dose levels of 300 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 150 mg BID (Single Agent

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 150 mg QD+azacitidine(Combination Therapy)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally QD in 28-day cycles at dose levels of 150 mg until MTD or MED achieved

Subject analysis set title

Phase 1: FT-2102 150 mg BID+azacitidine(Combination Therapy)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase: FT-2102 150 mg BID (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 150 mg BID+azacitidine(Combination Therapy)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 150 mg BID (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: Total FT-2102 (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the different dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102+azacitidine (Combination Therapy)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102 (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with acute AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Subject analysis set title

Phase 1: Total FT-2102 (Single Agent)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the different dose levels (150 mg and ≤ 300 mg) until MTD or MED achieved.

Subject analysis set title

Phase 1: FT-2102+azacitidine (Combination Therapy)

Subject analysis set type

Full analysis

Subject analysis set description

Subjects with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Primary: Phase 1: Number of Subjects With Treatment emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

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End point title

Phase 1: Number of Subjects With Treatment emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) ^[1] ^[2]

End point description

A TEAE was defined as an AE with onset on or after start of study drug, or any worsening of preexisting medical condition/AE with onset on or after start of study drug and until 28 days after last dose. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with use of product, whether or not considered related to product. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death,or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. Number of subjects with TEAEs and SAEs is reported. Safety analysis set included all subjects who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).

End point type

Primary

End point timeframe

Phase 1: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)

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: The primary endpoint investigated safety and was analysed using descriptive statistics, and thus no statistical analysis was performed.
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint applicable for the reported arms only.

End point values	Phase1:TotalFT-2102;FT-2102+azacitidine(Combination Therapy)	Phase 1: FT-2102 (Single Agent)	Phase 1: Total FT-2102 (Single Agent)	Phase 1: FT-2102 + azacitidine (Combination Therapy)
Number of subjects analysed	46	16	31	39
Units: Subjects
TEAEs	46	16	31	39
SAEs	36	10	23	30

No statistical analyses for this end point

Primary: Phase 1: Number of Subjects With Change From Baseline in Clinically Significant Abnormal Laboratory Values

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End point title

Phase 1: Number of Subjects With Change From Baseline in Clinically Significant Abnormal Laboratory Values ^[3] ^[4]

End point description

Number of subjects with change from baseline in clinically significant abnormal laboratory values for hematology, chemistry and coagulation with Grade <1 to 4 is reported. National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 toxicity grade used to determine severity of AE. Grade 1: mild;asymptomatic/mild symptoms; Grade 2: moderate; minimal; Grade 3: severe/medically significant; Grade 4: life-threatening consequences, Grade 5: death. Activated partial Thromboplastin signifies as "APT". Safety analysis set included all the subjects who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).

End point type

Primary

End point timeframe

Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months)

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: The primary endpoint investigated safety and was analysed using descriptive statistics, and thus no statistical analysis was performed.
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint applicable for the reported arms only.

End point values	Phase1:TotalFT-2102;FT-2102+azacitidine(Combination Therapy)	Phase 1: FT-2102 (Single Agent)	Phase 1: Total FT-2102 (Single Agent)	Phase 1: FT-2102 + azacitidine (Combination Therapy)
Number of subjects analysed	46	16	31	39
Units: Subjects
Hematology: Hemoglobin; Increase(Grade <1)	45	15	30	38
Hematology: Hemoglobin; Increase (Grade 1)	0	0	0	0
Hematology: Hemoglobin; Increase (Grade 2)	1	0	1	1
Hematology: Hemoglobin; Increase (Grade 3)	0	0	0	0
Hematology: Hemoglobin; Increase (Grade 4)	0	0	0	0
Hematology: Hemoglobin; Increase (Grade 3 or 4)	0	0	0	0
Hematology: Hemoglobin; Decrease (Grade <1)	0	0	0	0
Hematology: Hemoglobin; Decrease (Grade 1)	0	3	3	0
Hematology: Hemoglobin; Decrease (Grade 2)	10	1	7	9
Hematology: Hemoglobin; Decrease (Grade 3)	36	11	20	30
Hematology: Hemoglobin; Decrease (Grade 4)	0	0	0	0
Hematology: Hemoglobin; Decrease(Grade 3 or 4)	36	11	20	30
Hematology: Platelets; Decrease (Grade <1)	0	1	2	0
Hematology: Platelets; Decrease (Grade 1)	0	2	2	0
Hematology: Platelets; Decrease (Grade 2)	3	0	1	3
Hematology: Platelets; Decrease (Grade 3)	6	1	5	5
Hematology: Platelets; Decrease (Grade 4)	37	11	20	31
Hematology: Platelets; Decrease Grade 3 or 4)	43	12	25	36
Hematology: Leukocytes; Increase (Grade <1)	43	14	28	36
Hematology: Leukocytes; Increase (Grade 1)	0	0	0	0
Hematology: Leukocytes; Increase (Grade 2)	0	0	0	0
Hematology: Leukocytes; Increase (Grade 3)	3	1	2	3
Hematology: Leukocytes; Increase (Grade 4)	0	0	0	0
Hematology: Leukocytes; Increase (Grade 3 or 4)	3	1	2	3
Hematology: Leukocytes; Decrease (Grade <1)	2	1	2	1
Hematology: Leukocytes: Decrease (Grade 1)	1	2	3	1
Hematology: Leukocytes; Decrease (Grade 2)	4	1	6	4
Hematology: Leukocytes; Decrease (Grade 3)	16	4	8	14
Hematology: Leukocytes; Decrease (Grade 4)	23	7	11	19
Hematology: Leukocytes; Decrease (Grade 3 or 4)	39	11	19	33
Hematology: Neutrophils; Decrease (Grade <1)	1	1	1	1
Hematology: Neutrophils; Decrease (Grade 1)	0	0	1	0
Hematology: Neutrophils; Decrease (Grade 2)	0	0	0	0
Hematology: Neutrophils; Decrease (Grade 3)	2	2	5	2
Hematology: Neutrophils; Decrease (Grade 4)	43	12	23	36
Hematology: Neutrophils; Decrease (Grade 3 or 4)	45	14	28	38
Hematology: Lymphocytes; Increase (Grade <1)	32	11	19	26
Hematology: Lymphocytes; Increase (Grade 1)	0	0	0	0
Hematology: Lymphocytes; Increase (Grade 2)	12	3	10	11
Hematology: Lymphocytes: Increase (Grade 3)	1	0	0	1
Hematology: Lymphocytes; Increase (Grade 4)	0	0	0	0
Hematology: Lymphocytes; Increase (Grade 3 or 4)	1	0	0	1
Hematology: Lymphocytes; Decrease(Grade <1)	2	1	3	2
Hematology: Lymphocytes; Decrease(Grade 1)	6	2	7	6
Hematology: Lymphocytes; Decrease(Grade 2)	14	5	6	10
Hematology: Lymphocytes; Decrease(Grade 3)	18	5	10	16
Hematology: Lymphocytes; Decrease(Grade 4)	5	1	3	4
Hematology: Lymphocytes; Decrease(Grade 3 or 4)	23	6	13	20
Chemistry: Creatinine; Increase (Grade <1)	3	0	3	2
Chemistry: Creatinine; Increase (Grade 1)	31	12	23	26
Chemistry: Creatinine; Increase (Grade 2)	11	3	4	10
Chemistry: Creatinine; Increase (Grade 3)	1	0	0	1
Chemistry: Creatinine; Increase (Grade 4)	0	0	0	0
Chemistry: Creatinine; Increase (Grade 3 or 4)	1	0	0	1
Chemistry: Calcium; Increase (Grade <1)	39	13	28	35
Chemistry: Calcium; Increase (Grade 1)	4	0	0	3
Chemistry: Calcium; Increase (Grade 2)	0	0	0	0
Chemistry: Calcium; Increase (Grade 3)	1	1	1	0
Chemistry: Calcium; Increase (Grade 4)	0	1	1	0
Chemistry: Calcium; Increase (Grade 3 or 4)	1	2	2	0
Chemistry: Calcium; Decrease(Grade <1)	16	6	12	13
Chemistry: Calcium; Decrease(Grade 1)	26	9	17	23
Chemistry: Calcium; Decrease(Grade 2)	1	0	1	1
Chemistry: Calcium; Decrease(Grade 3)	1	0	0	1
Chemistry: Calcium; Decrease(Grade 4)	0	0	0	0
Chemistry: Calcium; Decrease(Grade 3 or 4)	1	0	0	1
Chemistry: Magnesium; Increase(Grade <1)	40	15	28	33
Chemistry: Magnesium; Increase(Grade 1)	0	0	0	0
Chemistry: Magnesium; Increase(Grade 2)	0	0	0	0
Chemistry: Magnesium; Increase(Grade 3)	5	0	2	5
Chemistry: Magnesium; Increase(Grade 4)	0	0	0	0
Chemistry: Magnesium; Increase(Grade 3 or 4)	5	0	2	5
Chemistry: Magnesium; Decrease(Grade <1)	26	8	17	24
Chemistry: Magnesium; Decrease(Grade 1)	19	7	13	14
Chemistry: Magnesium; Decrease(Grade 2)	0	0	0	0
Chemistry: Magnesium; Decrease(Grade 3)	0	0	0	0
Chemistry: Magnesium; Decrease(Grade 4)	0	0	0	0
Chemistry: Magnesium; Decrease(Grade 3 or 4)	0	0	0	0
Chemistry: Potassium; Increase(Grade <1)	40	13	24	34
Chemistry: Potassium; Increase(Grade 1)	4	1	5	3
Chemistry: Potassium; Increase(Grade 2)	2	1	1	2
Chemistry: Potassium; Increase(Grade 3)	0	0	0	0
Chemistry: Potassium; Increase(Grade 4)	0	0	0	0
Chemistry: Potassium; Increase(Grade 3 or 4)	0	0	0	0
Chemistry: Potassium; Decrease(Grade <1)	23	10	16	21
Chemistry: Potassium; Decrease(Grade 1)	19	3	10	14
Chemistry: Potassium; Decrease(Grade 2)	0	0	0	0
Chemistry: Potassium; Decrease(Grade 3)	4	2	4	4
Chemistry: Potassium; Decrease(Grade 4)	0	0	0	0
Chemistry: Potassium; Decrease (Grade 3 or 4)	4	2	4	4
Chemistry: Sodium; Increase (Grade <1)	41	13	27	34
Chemistry: Sodium; Increase (Grade 1)	5	2	3	5
Chemistry: Sodium; Increase (Grade 2)	0	0	0	0
Chemistry: Sodium; Increase (Grade 3)	0	0	0	0
Chemistry: Sodium; Increase (Grade 4)	0	0	0	0
Chemistry: Sodium; Increase (Grade 3 or 4)	0	0	0	0
Chemistry: Sodium; Decrease (Grade <1)	19	7	15	17
Chemistry: Sodium; Decrease (Grade 1)	24	7	11	19
Chemistry: Sodium; Decrease (Grade 2)	0	0	0	0
Chemistry: Sodium; Decrease (Grade 3)	3	1	4	3
Chemistry: Sodium; Decrease (Grade 4)	0	0	0	0
Chemistry: Sodium; Decrease (Grade 3 or 4)	3	1	4	3
Chemistry: Uric acid; Increase (Grade <1)	31	10	21	25
Chemistry: Uric acid; Increase (Grade 1)	10	5	9	10
Chemistry: Uric acid; Increase (Grade 2)	0	0	0	0
Chemistry: Uric acid; Increase (Grade 3)	0	0	0	0
Chemistry: Uric acid; Increase (Grade 4)	4	0	0	3
Chemistry: Uric acid; Increase (Grade 3 or 4)	4	0	0	3
Chemistry: Albumin; Decrease(Grade <1)	16	6	12	14
Chemistry: Albumin; Decrease(Grade 1)	12	5	10	12
Chemistry: Albumin; Decrease(Grade 2)	16	2	6	12
Chemistry: Albumin; Decrease(Grade 3)	1	2	2	0
Chemistry: Albumin; Decrease(Grade 4)	0	0	0	0
Chemistry: Albumin; Decrease(Grade 3 or 4)	1	2	2	0
Chemistry: Glucose; Increase (Grade <1)	40	13	26	33
Chemistry: Glucose; Increase (Grade 1)	0	0	0	0
Chemistry: Glucose; Increase (Grade 2)	0	0	0	0
Chemistry: Glucose; Increase (Grade 3)	5	1	2	5
Chemistry: Glucose; Increase (Grade 4)	0	1	2	0
Chemistry: Glucose; Increase (Grade 3 or 4)	5	2	4	5
Chemistry: Glucose; Decrease(Grade <1)	39	14	29	32
Chemistry: Glucose; Decrease(Grade 1)	5	1	1	5
Chemistry: Glucose; Decrease(Grade 2)	1	0	0	1
Chemistry: Glucose; Decrease(Grade 3)	0	0	0	0
Chemistry: Glucose; Decrease(Grade 4)	0	0	0	0
Chemistry: Glucose; Decrease(Grade 3 or 4)	0	0	0	0
Chemistry: Lipase; Increase (Grade <1)	18	2	2	18
Chemistry: Lipase; Increase (Grade 1)	0	1	1	0
Chemistry: Lipase; Increase (Grade 2)	0	0	0	0
Chemistry: Lipase; Increase (Grade 3)	2	1	1	2
Chemistry: Lipase; Increase (Grade 4)	0	0	0	0
Chemistry: Lipase; Increase (Grade 3 or 4)	2	1	1	2
Chemistry: Amylase; Decrease(Grade <1)	19	4	5	19
Chemistry: Amylase; Decrease(Grade 1)	0	0	0	0
Chemistry: Amylase; Decrease(Grade 2)	0	0	0	0
Chemistry: Amylase; Decrease(Grade 3)	0	0	0	0
Chemistry: Amylase; Decrease(Grade 4)	0	0	0	0
Chemistry: Amylase; Decrease(Grade 3 or 4)	0	0	0	0
Coagulation: APT Time; Increase(Grade <1)	21	6	7	20
Coagulation: APT Time; Increase(Grade 1)	2	1	1	2
Coagulation: APT Time; Increase(Grade 2)	1	0	0	1
Coagulation: APT Time; Increase(Grade 3)	1	0	0	1
Coagulation: APT Time; Increase(Grade 4)	0	0	0	0
Coagulation: APT Time; Increase (Grade 3 or 4)	1	0	0	1

No statistical analyses for this end point

Primary: Phase 1: Number of Subjects With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)

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End point title

Phase 1: Number of Subjects With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG) ^[5] ^[6]

End point description

Number of subjects with change from baseline in clinically significant abnormal ECG parameter (QTcF) is reported. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Safety analysis set included all the subjects who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine). Here, Number of subjects analysed (N)=subjects with available data for this endpoint.

End point type

Primary

End point timeframe

Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months)

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: The primary endpoint investigated safety and was analysed using descriptive statistics, and thus no statistical analysis was performed.
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint applicable for the reported arms only.

End point values	Phase1:TotalFT-2102;FT-2102+azacitidine(Combination Therapy)	Phase 1: FT-2102 (Single Agent)	Phase 1: Total FT-2102 (Single Agent)	Phase 1: FT-2102 + azacitidine (Combination Therapy)
Number of subjects analysed	45	15	30	38
Units: Subjects
<=450 msec	26	10	16	23
>450 to <=480 msec	13	4	11	10
>480 to <=500 msec	2	0	2	1
>500 msec	4	1	1	4
>30 to <=60 msec	14	2	8	13
>60 msec	6	1	2	5

No statistical analyses for this end point

Primary: Phase 2, Cohort 3, 4, 5, 6, 7, 8: Percentage of Subjects with CR Plus CRh for Acute Myeloid Leukemia Assessed by Investigator Based on IWG Response Criteria

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End point title

Phase 2, Cohort 3, 4, 5, 6, 7, 8: Percentage of Subjects with CR Plus CRh for Acute Myeloid Leukemia Assessed by Investigator Based on IWG Response Criteria ^[7] ^[8]

End point description

Percentage of subjects with CR plus CRh (CR, Molecular CR [CRm]), Cytogenetic CR [CRc], CRh) is re-ported. CR is defined as bone marrow blasts <5 % (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, ANC >=1000/μL, platelet count >=100,000/μL and transfusion independence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is de-fined as CR with undetectable IDH1m MRD and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count >50 × 10^9/L and ANC >0.5 × 10^9/L). Full analysis set included all the subjects who were enrolled in the study and have received at least one dose of FT-2102. This endpoint is applicable for Cohort 3, 4, 5, 6, 7 and 8. Here, N= subjects with available data for this endpoint.

End point type

Primary

End point timeframe

Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)

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: The primary endpoint was analysed using descriptive statistics, and thus no statistical analysis was performed.
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint applicable for the reported arms only.

End point values	Phase 2: Cohort 3; FT-2102 (Single Agent)	Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 6; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 7; FT-2102 (Single Agent)	Phase 2: Cohort 8; FT-2102+azacitidine (Combination Therapy)
Number of subjects analysed	5	19	13	20	10	11
Units: Percentage of subjects
number (confidence interval 95%)	0 (0.0 to 52.2)	47 (24.4 to 71.1)	38 (13.9 to 68.4)	30 (11.9 to 54.3)	40 (12.2 to 73.8)	45 (16.7 to 76.6)

No statistical analyses for this end point

Primary: Phase 2, Cohort 1: Percentage of Subjects with Complete Remission (CR) Plus Complete Remission with Partial Hematological Recovery (CRh) for Acute Myeloid Leukemia Assessed by Investigator Based on International Working Group (IWG) Response Criteria

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End point title

Phase 2, Cohort 1: Percentage of Subjects with Complete Remission (CR) Plus Complete Remission with Partial Hematological Recovery (CRh) for Acute Myeloid Leukemia Assessed by Investigator Based on International Working Group (IWG) Response Criteria ^[9] ^[10]

End point description

Percentage of subjects with CR plus CRh (CR, Molecular CR [CRm], Cytogenetic CR [CRc], CRh) is reported. CR is defined as bone marrow blasts less than (<) 5 percent (%) (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, absolute neutrophil count (ANC) greater than or equal to (>=) 1000/μL, platelet count >=100,000/μL and transfusion independence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is defined as CR with undetectable IDH1m minimal residual disease (MRD) and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count >50*10^9/L and ANC > 0.5*10^9/L). Efficacy evaluable analysis set included all subjects in Phase 2, Cohort 1 with confirmed IDH1-R132 who have received the first dose of FT-2102 180 days or more prior to the analysis cutoff date. This endpoint is applicable only for Cohort 1.

End point type

Primary

End point timeframe

Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)

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

End point values	Phase 2: Cohort 1; FT-2102 (Single Agent)
Number of subjects analysed	147
Units: Percentage of Subjects
number (confidence interval 95%)	35 (27.0 to 43.0)

No statistical analyses for this end point

Primary: Phase 2: Percentage of Subjects with CR for MDS Assessed by IWG Response Criteria

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End point title

Phase 2: Percentage of Subjects with CR for MDS Assessed by IWG Response Criteria ^[11] ^[12]

End point description

Percentage of subjects with complete remission (CR) is reported. CR is defined as bone marrow blast ≤ 5% myeloblasts with normal maturation of all cell lines, peripheral blood: Hgb ≥11 grams per deciliter (g/dL), platelets ≥ 100 × 10^9/L, neutrophils ≥ 1.0 × 10^9/L and blasts 0%. FAS included all the subjects who were enrolled in the study and have received at least one dose of FT-2102. This endpoint is applicable for Cohort 4 and 5. Here, N= subjects with available data for this endpoint.

End point type

Primary

End point timeframe

Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months)

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

End point values	Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)
Number of subjects analysed	1	8
Units: Percentage of subjects
number (confidence interval 95%)	0 (0.0 to 97.5)	13 (0.3 to 52.7)

No statistical analyses for this end point

Primary: Phase 2: Four-month Relapse Free survival (RFS) Rate (Cohort 2)

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End point title

Phase 2: Four-month Relapse Free survival (RFS) Rate (Cohort 2) ^[13] ^[14]

End point description

RFS is defined as the time between the date of first dose until relapse or death from any cause, whichever occurs first. RFS is calculated for all subjects in Phase 2 Cohort 2. 4-Month RFS rate is defined as the proportion of subjects in Phase 2 Cohort 2 who have not relapsed or died on or before their 4-month response evaluation. Full analysis set included all the subjects who were enrolled in the study and have received at least one dose of FT-2102.

End point type

Primary

End point timeframe

Phase 2: From the date of first dose until relapse or death from any cause, whichever occurs first (up to 82 months)

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

End point values	Phase 2: Cohort 2; FT-2102 (Single Agent)
Number of subjects analysed	18
Units: Percentage of subjects
number (confidence interval 95%)	83 (58.6 to 96.4)

No statistical analyses for this end point

Secondary: Phase 1: Area Under the Curve (AUClast) for FT-2102

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End point title

Phase 1: Area Under the Curve (AUClast) for FT-2102

End point description

Area under the plasma concentration-time curve from zero time until the last measurable concentration is presented. The pharmacokinetic (PK) analysis set included those subjects for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, number anaylsed (n) = subjects with available data for specific timepoints.

End point type

Secondary

End point timeframe

Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)

End point values	Phase 1: FT-2102 100 mg QD (Single Agent)	Phase 1: FT-2102 150 mg QD (Single Agent)	Phase 1: FT-2102 300 mg QD (Single Agent)	Phase 1: FT-2102 150 mg BID (Single Agent	Phase 1: FT-2102 150 mg QD+azacitidine(Combination Therapy)	Phase 1: FT-2102 150 mg BID+azacitidine(Combination Therapy)
Number of subjects analysed	3	8	4	6	7	8
Units: Hournanograms per millilitre (hng/mL)
geometric mean (geometric coefficient of variation)
Cycle 1 Day 1 (n=3, 8, 4, 6, 7, 8)	5505 ( 146.9 )	8955 ( 63.7 )	12100 ( 75.4 )	2538 ( 34.2 )	8529 ( 51.1 )	2288 ( 71.7 )
Cycle 2 Day 1 (n= 3, 5, 4, 6, 6, 5)	13080 ( 63.5 )	14130 ( 124.0 )	19140 ( 24.0 )	26360 ( 22.3 )	7468 ( 92.6 )	20640 ( 71.0 )

No statistical analyses for this end point

Secondary: Phase 1: Maximum Plasma Concentration (Cmax) for FT-2102

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End point title

Phase 1: Maximum Plasma Concentration (Cmax) for FT-2102

End point description

Maximum plasma concentration (Cmax) for FT-2102 is presented. The PK analysis set included those subjects for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, number anaylsed (n) = subjects with available data for specific timepoints.

End point type

Secondary

End point timeframe

Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)

End point values	Phase 1: FT-2102 100 mg QD (Single Agent)	Phase 1: FT-2102 150 mg QD (Single Agent)	Phase 1: FT-2102 300 mg QD (Single Agent)	Phase 1: FT-2102 150 mg QD+azacitidine(Combination Therapy)	Phase: FT-2102 150 mg BID (Single Agent)	Phase 1: FT-2102 150 mg BID+azacitidine(Combination Therapy)
Number of subjects analysed	3	8	4	7	6	8
Units: Nanograms per millilitre (ng/mL)
geometric mean (geometric coefficient of variation)
Cycle 1 Day 1 (n=3, 8, 4, 6, 7, 8)	571.5 ( 53.1 )	535.0 ( 58.7 )	708.0 ( 58.2 )	543.3 ( 39.8 )	495.5 ( 37.4 )	439.9 ( 56.2 )
Cycle 2 Day 1 (n=3, 5, 4, 6, 6, 5)	1913 ( 47.9 )	1998 ( 112.9 )	2907 ( 36.1 )	1101 ( 75.4 )	3703 ( 20.8 )	3183 ( 51.5 )

No statistical analyses for this end point

Secondary: Phase 1: Time to Maximum Plasma Concentration (Tmax) for FT-2102

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End point title

Phase 1: Time to Maximum Plasma Concentration (Tmax) for FT-2102

End point description

Time to reach the maximum plasma concentration (Tmax) is presented. The PK analysis set included those subjects for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, number anaylsed (n) = subjects with available data for specific timepoints.

End point type

Secondary

End point timeframe

Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)

End point values	Phase 1: FT-2102 100 mg QD (Single Agent)	Phase 1: FT-2102 150 mg QD (Single Agent)	Phase 1: FT-2102 300 mg QD (Single Agent)	Phase 1: FT-2102 150 mg QD+azacitidine(Combination Therapy)	Phase 1: FT-2102 150 mg BID+azacitidine(Combination Therapy)	Phase 1: FT-2102 150 mg BID (Single Agent)
Number of subjects analysed	3	8	4	7	8	6
Units: hour
median (full range (min-max))
Cycle 1 Day 1 (n=3, 8, 4, 6, 7, 8)	4.05 (2.22 to 4.12)	4.00 (2.02 to 24.00)	23.83 (4.00 to 24.00)	4.02 (2.00 to 22.55)	3.13 (2.03 to 4.12)	5.79 (1.00 to 7.83)
Cycle 2 Day 1 (n=3, 5, 4, 6, 6, 5)	2.23 (2.13 to 4.00)	2.00 (1.00 to 2.12)	1.00 (0.00 to 1.08)	2.29 (2.00 to 4.00)	1.18 (0.00 to 2.07)	3.00 (0.00 to 7.50)

No statistical analyses for this end point

Secondary: Phase 1: Time to Response (TTR) for AML

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End point title

Phase 1: Time to Response (TTR) for AML ^[15]

End point description

TTR is the time in months between the first dose of study drug and documentation of the first overall response for subjects who achieve a PR or better. This analysis was performed only on subjects who have achieved PR or better as a best overall response. FAS included all the subjects who were enrolled in the study and have received at least one dose of FT-2102. Here, N= subjects with PR or better as a best overall response.

End point type

Secondary

End point timeframe

Phase 1: Time from first dose of study drug until documentation of the first overall response (up to 82 months)

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

End point values	Phase1:TotalFT-2102;FT-2102+azacitidine(Combination Therapy)	Phase 1: FT-2102 (Single Agent)	Phase 1: Total FT-2102 (Single Agent)	Phase 1: FT-2102+azacitidine (Combination Therapy)
Number of subjects analysed	22	5	10	18
Units: Months
median (full range (min-max))	1.90 (1.0 to 5.6)	1.90 (1.0 to 2.9)	1.90 (1.0 to 4.7)	1.90 (1.0 to 5.6)

No statistical analyses for this end point

Secondary: Phase 1: Duration of Overall Response for AML

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End point title

Phase 1: Duration of Overall Response for AML ^[16]

End point description

Duration of response is defined as the time from the date of the first response to the date of the relapse or death. FAS included all the subjects who were enrolled in the study and have received at least one dose of FT-2102. Here, N = subjects with available data for this endpoint. Here 99999 signifies that since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.

End point type

Secondary

End point timeframe

Phase 1: From date of the first response to the date of the relapse or death (up to 82 months)

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

End point values	Phase1:TotalFT-2102;FT-2102+azacitidine(Combination Therapy)	Phase 1: FT-2102 (Single Agent)	Phase 1: Total FT-2102 (Single Agent)	Phase 1: FT-2102+azacitidine (Combination Therapy)
Number of subjects analysed	22	5	10	18
Units: Months
median (confidence interval 95%)	22.00 (3.20 to 99999)	3.60 (1.70 to 99999)	2.90 (0.90 to 6.40)	22.00 (3.20 to 99999)

No statistical analyses for this end point

Secondary: Phase 1: Time to Response (TTR) for MDS

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End point title

Phase 1: Time to Response (TTR) for MDS ^[17]

End point description

End point type

Secondary

End point timeframe

Phase 1: Time from first dose of study drug until documentation of the first overall response (up to 82 months)

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

End point values	Phase1:TotalFT-2102;FT-2102+azacitidine(Combination Therapy)	Phase 1: FT-2102 (Single Agent)	Phase 1: Total FT-2102 (Single Agent)	Phase 1: FT-2102+azacitidine (Combination Therapy)
Number of subjects analysed	6	2	2	6
Units: Months
median (full range (min-max))	2.20 (1.0 to 8.5)	4.65 (1.0 to 8.3)	4.65 (1.0 to 8.3)	2.20 (1.0 to 8.5)

No statistical analyses for this end point

Secondary: Phase 2: Time to Response (TTR) for Acute Myeloid Leukemia (AML)

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End point title

Phase 2: Time to Response (TTR) for Acute Myeloid Leukemia (AML) ^[18]

End point description

End point type

Secondary

End point timeframe

Phase 2: Time from first dose of study drug until documentation of the first overall response (up to 82 months)

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

End point values	Phase 2: Cohort 1; FT-2102 (Single Agent)	Phase 2: Cohort 3; FT-2102 (Single Agent)	Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 6; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 7; FT-2102 (Single Agent)	Phase 2: Cohort 8; FT-2102+azacitidine (Combination Therapy)
Number of subjects analysed	75	0 ^[19]	13	6	8	5	7
Units: Months
median (full range (min-max))	1.90 (0.9 to 10.2)	( to )	1.80 (0.9 to 3.8)	2.50 (1.0 to 4.2)	2.50 (1.0 to 7.6)	1.90 (1.8 to 3.9)	2.80 (1.1 to 5.6)

Notes
[19] - Subjects were not evaluated

No statistical analyses for this end point

Secondary: Phase 2: Duration of Overall Response for Acute Myeloid Leukemia (AML)

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End point title

Phase 2: Duration of Overall Response for Acute Myeloid Leukemia (AML) ^[20]

End point description

Duration of overall response is defined as the time from the date of the first response to the date of the relapse or death. FAS included all the subjects who were enrolled in the study and have received at least one dose of FT-2102. Data is reported only for Cohort 1, 4, 5, 6, 7 and 8. No subjects achieved an overall response in Phase 2 Cohort 3. Duration of Response is not calculated for Phase 2 Cohort 2. Here, N = subjects with overall response for this endpoint. Here 99999 signifies that since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.

End point type

Secondary

End point timeframe

Phase 2: From the date of the first response to the date of the relapse or death (up to 82 months)

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

End point values	Phase 2: Cohort 1; FT-2102 (Single Agent)	Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 6; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 7; FT-2102 (Single Agent)	Phase 2: Cohort 8; FT-2102+azacitidine (Combination Therapy)
Number of subjects analysed	75	13	6	8	5	7
Units: Months
median (confidence interval 95%)	14.80 (7.40 to 19.40)	20.00 (1.90 to 28.80)	7.25 (4.90 to 99999)	4.65 (2.80 to 99999)	10.60 (3.5 to 39.6)	20.90 (5.60 to 99999)

No statistical analyses for this end point

Secondary: Phase 2: Time to Response (TTR) for Myelodysplastic Syndrome (MDS)

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End point title

Phase 2: Time to Response (TTR) for Myelodysplastic Syndrome (MDS) ^[21]

End point description

TTR is the time in months between the first dose of study drug and documentation of the first overall response for subjects who achieve a PR or better. This analysis was performed only on subjects who have achieved PR or better as a best overall response. FAS included all the subjects who were enrolled in the study and have received at least one dose of FT-2102. This endpoint is applicable for Cohort 4 and 5. Here, N= participants with PR or better as a best overall response.

End point type

Secondary

End point timeframe

Phase 2: Time from first dose of study drug until documentation of the first overall response (up to 82 months)

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

End point values	Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)
Number of subjects analysed	1	4
Units: Months
median (full range (min-max))	3.30 (3.3 to 3.3)	1.50 (1.0 to 13.0)

No statistical analyses for this end point

Secondary: Phase 2: Duration of Overall Response for Myelodysplastic Syndrome (MDS)

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End point title

Phase 2: Duration of Overall Response for Myelodysplastic Syndrome (MDS) ^[22]

End point description

Duration of overall response is defined as the time from the date of the first response to the date of the relapse or death. FAS included all the subjects who were enrolled in the study and have received at least one dose of FT-2102. This endpoint is applicable for Cohort 4 and 5. Here, N = subjects with overall response for this endpoint. Here 99999 signifies that median, upper and lower limit of 95% CI could not be calculated since there is only one subject for Cohort 4 and since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median for Cohort 5.

End point type

Secondary

End point timeframe

Phase 2: From the documentation of the first response of PR or better until the date of relapse, death, whichever is earlier (up to 82 months)

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

End point values	Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)
Number of subjects analysed	1	4
Units: Months
median (confidence interval 95%)	99999 (99999 to 99999)	11.90 (2.8 to 99999)

No statistical analyses for this end point

Secondary: Phase 2 Cohort 2: Time to Relapse-Free Survival (RFS)

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End point title

Phase 2 Cohort 2: Time to Relapse-Free Survival (RFS) ^[23]

End point description

RFS was calculated for all subjects in Phase 2 Cohort 2. RFS is defined as the time (in months) between the date of first dose until relapse or death from any cause, whichever occurs first. Relapse free survival time to event is reported for all subjects in Cohort 2. FAS included all the subjects who were enrolled in the study and have received at least one dose of FT-2102. Here 99999 signifies that since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.

End point type

Secondary

End point timeframe

Phase 2: From the date of first dose until relapse or death from any cause, whichever occurs first (up to 82 months)

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

End point values	Phase 2: Cohort 2; FT-2102 (Single Agent)
Number of subjects analysed	18
Units: Months
median (confidence interval 95%)	18.40 (9.50 to 99999)

No statistical analyses for this end point

Secondary: Phase 2: Overall Survival (OS)

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End point title

Phase 2: Overall Survival (OS) ^[24]

End point description

OS is defined as the time in months from the first dose of study drug until death from any cause. For the subjects who are not known to have died by the end of study follow-up, OS will be censored on the date the subjects was last known to be alive. OS is calculated using Kaplan-Meier method. FAS included all the subjects who were enrolled in the study and have received at least one dose of FT-2102. Here, 99999 signifies since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median and the median was not reached, since more than half of the subjects in the study had not experienced the event of death at the time of analysis.

End point type

Secondary

End point timeframe

Phase 2: From first dose of study drug until death from any cause (up to 82 months)

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

End point values	Phase 2: Cohort 1; FT-2102 (Single Agent)	Phase 2: Cohort 2; FT-2102 (Single Agent)	Phase 2: Cohort 3; FT-2102 (Single Agent)	Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 6; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 7; FT-2102 (Single Agent)	Phase 2: Cohort 8; FT-2102+azacitidine (Combination Therapy)
Number of subjects analysed	153	18	5	20	21	20	10	11
Units: Months
median (confidence interval 95%)	11.60 (8.90 to 15.50)	99999 (27.30 to 99999)	1.20 (1.10 to 99999)	25.20 (13.60 to 99999)	11.60 (5.00 to 27.50)	10.20 (4.40 to 17.90)	14.00 (1.00 to 19.10)	18.70 (1.60 to 99999)

No statistical analyses for this end point

Secondary: Phase 2: Event-free survival (EFS)

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End point title

Phase 2: Event-free survival (EFS) ^[25]

End point description

EFS is defined as the time in months between first dose of study drug and disease progression, relapse, death from any cause, treatment failure, or start of other (non-protocol study drug) new antileukemia therapy, whichever occurs first. FAS included all the subjects who were enrolled in the study and have received at least one dose of FT-2102. Here 99999 signifies that since the upper confidence limits for the survivor function lies above 0.5, it is not possible to estimate the upper confidence limit for the median.

End point type

Secondary

End point timeframe

Phase 2: From first dose of study drug to disease progression, relapse, death from any cause, treatment failure, or start of other (non-protocol study drug) new antileukemia therapy (up to 82 months)

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

End point values	Phase 2: Cohort 1; FT-2102 (Single Agent)	Phase 2: Cohort 2; FT-2102 (Single Agent)	Phase 2: Cohort 3; FT-2102 (Single Agent)	Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 6; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 7; FT-2102 (Single Agent)	Phase 2: Cohort 8; FT-2102+azacitidine (Combination Therapy)
Number of subjects analysed	153	18	5	20	21	20	10	11
Units: Months
median (confidence interval 95%)	5.50 (4.30 to 7.40)	18.40 (9.50 to 99999)	1.05 (0.80 to 99999)	5.70 (1.90 to 16.40)	7.80 (2.10 to 10.20)	4.80 (2.50 to 9.70)	5.50 (0.30 to 99999)	8.10 (1.60 to 33.00)

No statistical analyses for this end point

Secondary: Phase 2: Transfusion Independence

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End point title

Phase 2: Transfusion Independence ^[26]

End point description

Transfusion independence is defined as the number of subjects who experience at least a 56-day period during any point on treatment without requiring a transfusion of RBC and/or platelet transfusion. Subjects are classified as either "dependent" or "independent" at baseline based on their transfusion history. Those who received either platelets or pRBC or both within 8 weeks prior to the first dose of FT-2102 are considered "dependent. FAS included all the subjects who were enrolled in the study and have received at least one dose of FT-2102. Number of subjects with transfusion independent is reported here.

End point type

Secondary

End point timeframe

Phase 2: From baseline (8 weeks prior to first dose) up to treatment period (up to 82 months)

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

End point values	Phase 2: Cohort 1; FT-2102 (Single Agent)	Phase 2: Cohort 2; FT-2102 (Single Agent)	Phase 2: Cohort 3; FT-2102 (Single Agent)	Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 6; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 7; FT-2102 (Single Agent)	Phase 2: Cohort 8; FT-2102+azacitidine (Combination Therapy)
Number of subjects analysed	153	18	5	20	21	20	10	11
Units: Subjects	72	15	0	12	13	14	3	8

No statistical analyses for this end point

Secondary: Phase 2: Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

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End point title

Phase 2: Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) ^[27]

End point description

A TEAE was defined as an AE with onset on or after the start of study drug, or any worsen-ing of a pre-existing medical condition/AE with onset on or after the start of study drug and until 28 days after the last dose. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A SAE is defined as any untoward medical occur-rence that at any dose results in death, or is life-threatening, or requires inpatient hospitalisation or causes prolongation of existing hospitalisation results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. Number of subjects with TEAEs and SAEs is reported. SAS included all the subjects who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).

End point type

Secondary

End point timeframe

Phase 2: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)

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

End point values	Phase 2: Cohort 1; FT-2102 (Single Agent)	Phase 2: Cohort 2; FT-2102 (Single Agent)	Phase 2: Cohort 3; FT-2102 (Single Agent)	Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 6; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 7; FT-2102 (Single Agent)	Phase 2: Cohort 8; FT-2102+azacitidine (Combination Therapy)
Number of subjects analysed	153	18	5	20	21	20	10	11
Units: Subjects
TEAEs	153	18	5	19	21	19	10	11
SAEs	115	6	4	12	18	13	8	9

No statistical analyses for this end point

Secondary: Phase 2: Number of Subjects With Change From Baseline in Clinically Significant Abnormal Laboratory Values

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End point title

Phase 2: Number of Subjects With Change From Baseline in Clinically Significant Abnormal Laboratory Values ^[28]

End point description

Number of subjects with change from baseline in clinically significant abnormal laboratory values for hematology, chemistry and coagulation with Grade <1 to 4 is reported. National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 toxicity grade used to determine severity of AE. Grade 1: mild;asymptomatic/mild symptoms; Grade 2: moderate; minimal; Grade 3: severe/medically significant; Grade 4: life-threatening consequences, Grade 5: death. Safety analysis set included all the subjects who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine).

End point type

Secondary

End point timeframe

Phase 2: From Baseline up to 28 days after last dose of study drug (up to 82 months)

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

End point values	Phase 2: Cohort 1; FT-2102 (Single Agent)	Phase 2: Cohort 2; FT-2102 (Single Agent)	Phase 2: Cohort 3; FT-2102 (Single Agent)	Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 6; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 7; FT-2102 (Single Agent)	Phase 2: Cohort 8; FT-2102+azacitidine (Combination Therapy)
Number of subjects analysed	153	18	5	20	21	20	10	11
Units: Subjects
Hematology: Hemoglobin; Increase (Grade <1)	146	18	5	19	20	20	10	10
Hematology: Hemoglobin; Increase (Grade 1)	1	0	0	0	1	0	0	0
Hematology: Hemoglobin; Increase (Grade 2)	0	0	0	0	0	0	0	0
Hematology: Hemoglobin; Increase (Grade 3)	5	0	0	0	0	0	0	1
Hematology: Hemoglobin; Increase (Grade 4)	0	0	0	0	0	0	0	0
Hematology: Hemoglobin; Increase (Grade 3 or 4)	5	0	0	0	0	0	0	1
Hematology: Hemoglobin; Decrease (Grade <1)	3	3	0	0	0	1	0	0
Hematology: Hemoglobin; Decrease (Grade 1)	17	8	0	1	0	2	1	0
Hematology: Hemoglobin; Decrease (Grade 2)	46	3	1	7	3	5	2	2
Hematology: Hemoglobin; Decrease (Grade 3)	86	4	4	11	18	12	7	9
Hematology: Hemoglobin; Decrease (Grade 4)	0	0	0	0	0	0	0	0
Hematology: Hemoglobin; Decrease (Grade 3 or 4)	86	4	4	11	18	12	7	9
Hematology: Platelets; Decrease (Grade <1)	3	3	0	0	0	0	1	0
Hematology: Platelets; Decrease (Grade 1)	19	8	0	1	0	3	0	0
Hematology: Platelets; Decrease (Grade 2)	14	3	0	2	1	1	0	2
Hematology: Platelets; Decrease (Grade 3)	25	3	1	3	2	5	2	3
Hematology: Platelets; Decrease (Grade 4)	91	1	4	13	18	11	7	6
Hematology: Platelets; Decrease (Grade 3 or 4)	116	4	5	16	20	16	9	9
Hematology: Leukocytes; Increase (Grade <1)	150	18	5	18	20	19	10	11
Hematology: Leukocytes; Increase (Grade 1)	0	0	0	0	0	0	0	0
Hematology: Leukocytes; Increase (Grade 2)	0	0	0	0	0	0	0	0
Hematology: Leukocytes; Increase (Grade 3)	2	0	0	1	1	1	0	0
Hematology: Leukocytes; Increase (Grade 4)	0	0	0	0	0	0	0	0
Hematology: Leukocytes; Increase (Grade 3 or 4)	2	0	0	1	1	1	0	0
Hematology: Leukocytes; Decrease (Grade <1)	17	1	2	0	2	2	3	0
Hematology: Leukocytes; Decrease (Grade 1)	8	2	0	0	1	3	0	0
Hematology: Leukocytes; Decrease (Grade 2)	20	7	0	3	0	0	2	0
Hematology: Leukocytes; Decrease (Grade 3)	50	6	1	4	6	5	3	4
Hematology: Leukocytes; Decrease (Grade 4)	57	2	2	12	12	10	2	7
Hematology: Leukocytes; Decrease (Grade 3 or 4)	107	8	3	16	18	15	5	11
Hematology: Neutrophils; Decrease (Grade <1)	1	2	0	1	0	3	1	0
Hematology: Neutrophils; Decrease (Grade 1)	2	1	0	0	1	0	0	0
Hematology: Neutrophils; Decrease (Grade 2)	6	5	0	0	0	0	1	0
Hematology: Neutrophils; Decrease (Grade 3)	21	4	0	1	1	1	2	0
Hematology: Neutrophils; Decrease (Grade 4)	117	6	5	17	19	15	6	10
Hematology: Neutrophils; Decrease (Grade 3 or 4)	138	10	5	18	20	16	8	10
Hematology: Lymphocytes; Increase (Grade <1)	103	17	2	14	19	14	8	8
Hematology: Lymphocytes; Increase (Grade 1)	0	0	0	0	0	0	0	0
Hematology: Lymphocytes; Increase (Grade 2)	36	1	3	5	1	4	2	1
Hematology: Lymphocytes; Increase (Grade 3)	4	0	0	0	1	0	0	0
Hematology: Lymphocytes; Increase (Grade 4)	0	0	0	0	0	0	0	0
Hematology: Lymphocytes; Increase (Grade 3 or 4)	4	0	0	0	1	0	0	0
Hematology: Lymphocytes; Decrease (Grade <1)	18	2	1	1	1	1	1	1
Hematology: Lymphocytes; Decrease (Grade 1)	18	1	0	0	1	4	1	0
Hematology: Lymphocytes; Decrease (Grade 2)	36	7	0	7	4	4	3	3
Hematology: Lymphocytes; Decrease (Grade 3)	44	7	4	7	10	6	4	5
Hematology: Lymphocytes; Decrease (Grade 4)	27	1	0	4	5	3	1	0
Hematology: Lymphocytes; Decrease (Grade 3 or 4)	71	8	4	11	15	9	5	5
Chemistry: Creatinine; Increase (Grade <1)	2	0	1	0	0	0	1	0
Chemistry: Creatinine; Increase (Grade 1)	92	13	3	13	10	14	3	8
Chemistry: Creatinine; Increase (Grade 2)	55	4	1	5	10	6	6	3
Chemistry: Creatinine; Increase (Grade 3)	3	0	0	1	1	0	0	0
Chemistry: Creatinine; Increase (Grade 4)	0	1	0	0	0	0	0	0
Chemistry: Creatinine; Increase (Grade 3 or 4)	3	1	0	1	1	0	0	0
Chemistry: Calcium; Increase (Grade <1)	126	16	4	14	18	16	7	9
Chemistry: Calcium; Increase (Grade 1)	14	1	1	3	1	3	1	2
Chemistry: Calcium; Increase (Grade 2)	2	0	0	0	1	1	0	0
Chemistry: Calcium; Increase (Grade 3)	0	0	0	0	0	0	0	0
Chemistry: Calcium; Increase (Grade 4)	4	0	0	1	1	0	0	0
Chemistry: Calcium; Increase (Grade 3 or 4)	4	0	0	1	1	0	0	0
Chemistry: Calcium; Decrease (Grade <1)	83	13	4	14	13	16	4	6
Chemistry: Calcium; Decrease (Grade 1)	50	4	0	3	7	3	4	4
Chemistry: Calcium; Decrease (Grade 2)	4	0	0	0	1	0	0	0
Chemistry: Calcium; Decrease (Grade 3)	2	0	1	0	0	1	0	0
Chemistry: Calcium; Decrease (Grade 4)	7	0	0	1	0	0	0	1
Chemistry: Calcium; Decrease (Grade 3 or 4)	9	0	1	1	0	1	0	1
Chemistry: Magnesium; Increase (Grade <1)	129	18	3	15	18	19	9	10
Chemistry: Magnesium; Increase (Grade 1)	13	0	2	1	3	1	0	1
Chemistry: Magnesium; Increase (Grade 2)	0	0	0	0	0	0	0	0
Chemistry: Magnesium; Increase (Grade 3)	9	0	0	2	0	0	1	0
Chemistry: Magnesium; Increase (Grade 4)	0	0	0	1	0	0	0	0
Chemistry: Magnesium; Increase (Grade 3 or 4)	9	0	0	3	0	0	1	0
Chemistry: Magnesium; Decrease (Grade <1)	103	14	2	11	17	10	7	6
Chemistry: Magnesium; Decrease (Grade 1)	39	4	3	8	4	8	3	5
Chemistry: Magnesium; Decrease (Grade 2)	8	0	0	0	0	2	0	0
Chemistry: Magnesium; Decrease (Grade 3)	1	0	0	0	0	0	0	0
Chemistry: Magnesium; Decrease (Grade 4)	0	0	0	0	0	0	0	0
Chemistry: Magnesium; Decrease (Grade 3 or 4)	1	0	0	0	0	0	0	0
Chemistry: Potassium; Increase (Grade <1)	120	12	5	17	16	16	7	9
Chemistry: Potassium; Increase (Grade 1)	28	4	0	2	4	2	3	2
Chemistry: Potassium; Increase (Grade 2)	4	2	0	0	1	2	0	0
Chemistry: Potassium; Increase (Grade 3)	0	0	0	0	0	0	0	0
Chemistry: Potassium; Increase (Grade 4)	0	0	0	0	0	0	0	0
Chemistry: Potassium; Increase (Grade 3 or 4)	0	0	0	0	0	0	0	0
Chemistry: Potassium; Decrease (Grade <1)	73	14	1	7	16	12	6	5
Chemistry: Potassium; Decrease (Grade 1)	64	4	3	8	4	6	3	5
Chemistry: Potassium; Decrease (Grade 2)	0	0	0	0	0	0	0	0
Chemistry: Potassium; Decrease (Grade 3)	9	0	0	4	1	2	1	1
Chemistry: Potassium; Decrease (Grade 4)	6	0	1	0	0	0	0	0
Chemistry: Potassium; Decrease (Grade 3 or 4)	15	0	1	4	1	2	1	1
Chemistry: Sodium; Increase (Grade <1)	139	17	4	18	19	20	9	8
Chemistry: Sodium; Increase (Grade 1)	13	0	0	1	2	0	1	3
Chemistry: Sodium; Increase (Grade 2)	0	1	1	0	0	0	0	0
Chemistry: Sodium; Increase (Grade 3)	0	0	0	0	0	0	0	0
Chemistry: Sodium; Increase (Grade 4)	0	0	0	0	0	0	0	0
Chemistry: Sodium; Increase (Grade 3 or 4)	0	0	0	0	0	0	0	0
Chemistry: Sodium; Decrease (Grade <1)	77	15	3	13	13	12	5	5
Chemistry: Sodium; Decrease (Grade 1)	62	2	2	5	8	7	4	6
Chemistry: Sodium; Decrease (Grade 2)	0	0	0	0	0	0	0	0
Chemistry: Sodium; Decrease (Grade 3)	12	0	0	0	0	1	1	0
Chemistry: Sodium; Decrease (Grade 4)	1	1	0	1	0	0	0	0
Chemistry: Sodium; Decrease (Grade 3 or 4)	13	1	0	1	0	1	1	0
Chemistry: Uric acid; Increase (Grade <1)	96	10	5	11	14	3	5	11
Chemistry: Uric acid; Increase (Grade 1)	49	8	0	6	5	6	4	0
Chemistry: Uric acid; Increase (Grade 2)	0	0	0	0	0	0	0	0
Chemistry: Uric acid; Increase (Grade 3)	0	0	0	0	0	0	0	0
Chemistry: Uric acid; Increase (Grade 4)	6	0	0	1	1	1	1	0
Chemistry: Uric acid; Increase (Grade 3 or 4)	6	0	0	1	1	1	1	0
Chemistry: Albumin; Decrease (Grade <1)	57	16	0	7	8	9	3	5
Chemistry: Albumin; Decrease (Grade 1)	41	1	2	6	7	6	2	2
Chemistry: Albumin; Decrease (Grade 2)	45	1	2	6	4	4	2	4
Chemistry: Albumin; Decrease (Grade 3)	8	0	1	0	2	1	3	0
Chemistry: Albumin; Decrease (Grade 4)	0	0	0	0	0	0	0	0
Chemistry: Albumin; Decrease (Grade 3 or 4)	8	0	1	0	2	1	3	0
Chemistry: Glucose; Increase (Grade <1)	134	18	5	17	19	18	9	10
Chemistry: Glucose; Increase (Grade 1)	0	0	0	0	0	0	0	0
Chemistry: Glucose; Increase (Grade 2)	0	0	0	0	0	0	0	0
Chemistry: Glucose; Increase (Grade 3)	16	0	0	2	1	2	1	1
Chemistry: Glucose; Increase (Grade 4)	1	0	0	0	0	0	0	0
Chemistry: Glucose; Increase (Grade 3 or 4)	17	0	0	2	1	2	1	1
Chemistry: Glucose; Decrease (Grade <1)	136	15	5	17	18	19	10	10
Chemistry: Glucose; Decrease (Grade 1)	13	3	0	1	0	1	0	1
Chemistry: Glucose; Decrease (Grade 2)	0	0	0	0	1	0	0	0
Chemistry: Glucose; Decrease (Grade 3)	0	0	0	0	0	0	0	0
Chemistry: Glucose; Decrease (Grade 4)	2	0	0	1	1	0	0	0
Chemistry: Glucose; Decrease (Grade 3 or 4)	2	0	0	1	1	0	0	0
Chemistry: Lipase; Increase (Grade <1)	108	8	5	12	16	17	8	7
Chemistry: Lipase; Increase (Grade 1)	13	4	0	3	5	1	0	3
Chemistry: Lipase; Increase (Grade 2)	12	3	0	2	0	1	1	0
Chemistry: Lipase; Increase (Grade 3)	11	1	0	0	0	1	1	0
Chemistry: Lipase; Increase (Grade 4)	1	0	0	0	0	0	0	1
Chemistry: Lipase; Increase (Grade 3 or 4)	12	1	0	0	0	1	0	1
Chemistry: Amylase; Decrease (Grade <1)	116	13	5	13	18	18	9	9
Chemistry: Amylase; Decrease (Grade 1)	24	3	0	3	2	0	1	1
Chemistry: Amylase; Decrease (Grade 2)	3	0	0	0	1	0	0	0
Chemistry: Amylase; Decrease (Grade 3)	4	0	0	0	0	0	0	1
Chemistry: Amylase; Decrease (Grade 4)	1	0	0	0	0	1	0	0
Chemistry: Amylase; Decrease (Grade 3 or 4)	5	0	0	0	0	1	0	1
Coagulation: APT Time; Increase (Grade <1)	82	14	0	13	13	8	4	5
Coagulation: APT Time; Increase (Grade 1)	15	0	1	0	3	2	0	3
Coagulation: APT Time; Increase (Grade 2)	1	0	0	1	0	0	0	0
Coagulation: APT Time; Increase (Grade 3)	1	0	0	0	0	0	0	0
Coagulation: APT Time; Increase (Grade 4)	0	0	0	0	0	0	0	0
Coagulation: APT Time; Increase (Grade 3 or 4)	1	0	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Phase 2: Number of Subjects With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)

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End point title

Phase 2: Number of Subjects With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG) ^[29]

End point description

Number of subjects with change from baseline in clinically significant abnormal ECG parameter (QTcF) is reported. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Safety analysis set included all the subjects who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine). Here, N= participants with available data for this endpoint.

End point type

Secondary

End point timeframe

Phase 2: From Baseline up to 28 days after last dose of study drug (up to 82 months)

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

End point values	Phase 2: Cohort 1; FT-2102 (Single Agent)	Phase 2: Cohort 2; FT-2102 (Single Agent)	Phase 2: Cohort 3; FT-2102 (Single Agent)	Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 6; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 7; FT-2102 (Single Agent)	Phase 2: Cohort 8; FT-2102+azacitidine (Combination Therapy)
Number of subjects analysed	151	17	5	18	21	20	10	11
Units: Subjects
<=450 msec	90	11	1	9	9	11	9	4
>450 to <=480 msec	44	3	3	6	7	5	0	4
>480 to <=500 msec	12	1	1	1	2	1	1	1
>500 msec	5	2	0	2	3	3	0	2
>30 to <=60 msec	43	3	2	3	4	7	3	1
>60 msec	10	0	0	3	1	2	0	5

No statistical analyses for this end point

Secondary: Phase 2: Area Under the Curve (AUClast) for FT-2102

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End point title

Phase 2: Area Under the Curve (AUClast) for FT-2102 ^[30]

End point description

Area under the plasma concentration-time curve from zero time until the last measurable concentration is presented. The PK analysis set included those subjects for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, N and number analysed (n) = subjects with available data for specific timepoints. Here, 99999 signifies geometric coefficient of variation could not be calculated due to small number of subjects.

End point type

Secondary

End point timeframe

Phase 2: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)

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

End point values	Phase 2: Cohort 1; FT-2102 (Single Agent)	Phase 2: Cohort 2; FT-2102 (Single Agent)	Phase 2: Cohort 3; FT-2102 (Single Agent)	Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 6; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 7; FT-2102 (Single Agent)	Phase 2: Cohort 8; FT-2102+azacitidine (Combination Therapy)
Number of subjects analysed	117	14	2	12	16	4	2	1
Units: h*ng/mL
geometric mean (geometric coefficient of variation)
Cycle 1 Day 1 (n=117, 14, 2, 12, 16, 3, 2 ,1)	2836 ( 59.5 )	2657 ( 36.8 )	1880 ( 77.4 )	3051 ( 109.7 )	2031 ( 69.4 )	1701 ( 39.4 )	4165 ( 116.5 )	3898 ( 99999 )
Cycle 2 Day 1 (n=88, 12, 0, 11, 14, 4, 1, 1)	20610 ( 69.7 )	27710 ( 14.9 )	0 ( 0 )	19820 ( 77.6 )	19610 ( 62.1 )	21810 ( 45.6 )	25880 ( 99999 )	19940 ( 99999 )

No statistical analyses for this end point

Secondary: Phase 2: Maximum Plasma Concentration (Cmax) for FT-2102

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End point title

Phase 2: Maximum Plasma Concentration (Cmax) for FT-2102 ^[31]

End point description

Maximum Plasma Concentartion (Cmax) for FT-2102 is presented. The PK analysis set included those subjects for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, N and number analysed (n) = subjects with available data for specific timepoints. Here, 99999 signifies geometric coefficient of variation could not be calculated due to small number of subjects.

End point type

Secondary

End point timeframe

Phase 2: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)

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

End point values	Phase 2: Cohort 1; FT-2102 (Single Agent)	Phase 2: Cohort 2; FT-2102 (Single Agent)	Phase 2: Cohort 3; FT-2102 (Single Agent)	Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 6; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 7; FT-2102 (Single Agent)	Phase 2: Cohort 8; FT-2102+azacitidine (Combination Therapy)
Number of subjects analysed	120	14	2	13	16	4	2	1
Units: ng/mL
geometric mean (geometric coefficient of variation)
Cycle 1 Day 1 (n=120, 14, 2, 13, 16, 4, 2 ,1)	534.5 ( 57.5 )	492.4 ( 29.3 )	388.8 ( 49.1 )	623.2 ( 75.8 )	404.1 ( 58.5 )	411.2 ( 9.0 )	747.5 ( 107.6 )	671 ( 99999 )
Cycle 2 Day 1 (n=88, 12, 0, 11, 14, 4, 1, 1)	3136 ( 62.0 )	3800 ( 14.7 )	0 ( 0 )	3239 ( 68.7 )	2934 ( 53.6 )	3043 ( 39.3 )	3500 ( 99999 )	3080 ( 99999 )

No statistical analyses for this end point

Secondary: Phase 2: Time to Maximum Plasma Concentration (Tmax) for FT-2102

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End point title

Phase 2: Time to Maximum Plasma Concentration (Tmax) for FT-2102 ^[32]

End point description

Time to reach the maximum plasma concentration (Tmax) for FT-2102 is presented. The PK analysis set included those subjects for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, N and number analysed (n) = subjects with available data for specific timepoints.

End point type

Secondary

End point timeframe

Phase 2: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days)

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

End point values	Phase 2: Cohort 1; FT-2102 (Single Agent)	Phase 2: Cohort 2; FT-2102 (Single Agent)	Phase 2: Cohort 3; FT-2102 (Single Agent)	Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 6; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 7; FT-2102 (Single Agent)	Phase 2: Cohort 8; FT-2102+azacitidine (Combination Therapy)
Number of subjects analysed	120	14	2	13	16	4	2	1
Units: hour
median (full range (min-max))
Cycle 1 Day 1 (n=120, 14, 2, 13, 16, 4, 2 ,1)	4.00 (1.00 to 8.00)	4.00 (2.00 to 8.00)	5.00 (2.00 to 8.00)	4.00 (2.00 to 8.00)	4.00 (2.00 to 8.00)	4.00 (2.00 to 8.00)	3.00 (2.00 to 4.00)	1.00 (1.00 to 1.00)
Cycle 2 Day 1 (n=88, 12, 0, 11, 14, 4, 1, 1)	2.00 (0.00 to 8.00)	1.00 (0.00 to 2.00)	0 (0 to 0)	1.00 (0.00 to 8.00)	1.00 (0.00 to 4.00)	4.00 (0.00 to 8.00)	0.00 (0 to 0)	1.00 (1.00 to 1.00)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months)

Adverse event reporting additional description

All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is an AE that emerges during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state. One subject received olutasidenib in combination with cytarabine. This subject is included in the Phase 1 Overall column.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

Phase 1:TotalFT-2102;FT-2102+azacitidine(Combination Therapy)

Reporting group description

Subjects with AML or MDS received combination therapy azacitidine (administered at the dose of 75 mg/m^2 for 7 days IV/SC per every 28-day cycle) until treatment discontinuation.

Reporting group title

Phase 1: FT-2102+azacitidine(Combination Therapy)

Reporting group description

Subjects with AML or MDS received combination therapy (FT-2102 + azacitidine 75 mg/m^2) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Reporting group title

Phase 1: Total FT-2102 (Single Agent)

Reporting group description

Subjects with AML or MDS received single agent FT-2102 orally QD and BID in 28-day cycles at the different dose levels (150 mg and 300 mg) until MTD or MED achieved.

Reporting group title

Phase 1: FT-2102 (Single Agent)

Reporting group description

Subjects with AML or MDS received single agent FT-2102 orally BID in 28-day cycles at dose levels of 150 mg until maximum MTD or maximum MED achieved.

Reporting group title

Phase 2: Cohort 7; FT-2102 (Single Agent)

Reporting group description

Reporting group title

Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)

Reporting group description

Subjects with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles.

Reporting group title

Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)

Reporting group description

Reporting group title

Phase 2: Cohort 6; FT-2102+azacitidine (Combination Therapy)

Reporting group description

Participants with R/R AML/MDS that have been previously treated with single agent FT-2102 as their last therapy prior to study enrolment received combination therapy of azacitidine + FT-2102 150 mg BID in continuous 28-day cycles. Participants from the FT-2102 single agent cohorts of this study allowed to be enrolled in Cohort 6 after their disease progression.

Reporting group title

Phase 2: Cohort 3; FT-2102 (Single Agent)

Reporting group description

Subjects with R/R AML or MDS who were previously treated with FT-2102 and who underwent HSCT on-study then relapsed post-HSCT received single agent of FT-2102 150 mg BID in continuous 28-day cycles.

Reporting group title

Phase 2: Cohort 8; FT-2102+azacitidine (Combination Therapy)

Reporting group description

Reporting group title

Phase 2: Cohort 1; FT-2102 (Single Agent)

Reporting group description

Subjects with R/R AML received single agent of FT-2102 150 mg BID in continuous 28-day cycles.

Reporting group title

Phase 1: Overall

Reporting group description

Subjects with AML or MDS received single agent, combination therapy (FT-2102 azacitidine, FT-2102+LDAC) orally BID in 28-day cycles at dose levels of 150 mg until MTD or MED achieved.

Reporting group title

Phase 2: Cohort 2; FT-2102 (Single Agent)

Reporting group description

Subjects with AML in morphologic CR/CRi after prior therapy with residual IDH1-R132 mutation were received single agent of FT-2102 150 mg BID in continuous 28-day cycles.

Phase 1:TotalFT-2102;FT-2102+azacitidine(Combination Therapy)

Phase 1: FT-2102+azacitidine(Combination Therapy)

Phase 1: Total FT-2102 (Single Agent)

Phase 1: FT-2102 (Single Agent)

Phase 2: Cohort 7; FT-2102 (Single Agent)

Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)

Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)

Phase 2: Cohort 6; FT-2102+azacitidine (Combination Therapy)

Phase 2: Cohort 3; FT-2102 (Single Agent)

Phase 2: Cohort 8; FT-2102+azacitidine (Combination Therapy)

Phase 2: Cohort 1; FT-2102 (Single Agent)

Phase 1: Overall

Phase 2: Cohort 2; FT-2102 (Single Agent)

Total subjects affected by serious adverse events

subjects affected / exposed

36 / 46 (78.26%)

30 / 39 (76.92%)

23 / 31 (74.19%)

10 / 16 (62.50%)

8 / 10 (80.00%)

12 / 20 (60.00%)

18 / 21 (85.71%)

13 / 20 (65.00%)

4 / 5 (80.00%)

9 / 11 (81.82%)

115 / 153 (75.16%)

60 / 78 (76.92%)

6 / 18 (33.33%)

number of deaths (all causes)

number of deaths resulting from adverse events

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

Malignant pleural effusion

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Malignant melanoma

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

1 / 11 (9.09%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular disorders

Aortic stenosis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (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

Arterial stenosis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

1 / 20 (5.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haematoma

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

1 / 31 (3.23%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (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

Hypertension

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

1 / 10 (10.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypotension

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

1 / 31 (3.23%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

1 / 20 (5.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

2 / 153 (1.31%)

2 / 78 (2.56%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

General disorders and administration site conditions

Death

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

1 / 31 (3.23%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

3 / 153 (1.96%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 3

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 3

0 / 1

0 / 0

Disease progression

subjects affected / exposed

5 / 46 (10.87%)

4 / 39 (10.26%)

3 / 31 (9.68%)

0 / 16 (0.00%)

1 / 10 (10.00%)

3 / 20 (15.00%)

4 / 21 (19.05%)

3 / 20 (15.00%)

1 / 5 (20.00%)

3 / 11 (27.27%)

25 / 153 (16.34%)

8 / 78 (10.26%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 5

0 / 4

0 / 3

0 / 0

0 / 1

0 / 3

0 / 4

0 / 3

0 / 1

0 / 3

1 / 25

0 / 8

0 / 0

deaths causally related to treatment / all

0 / 5

0 / 4

0 / 3

0 / 0

0 / 1

0 / 4

0 / 3

0 / 1

0 / 2

1 / 22

0 / 8

0 / 0

Fatigue

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

1 / 31 (3.23%)

1 / 16 (6.25%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

2 / 78 (2.56%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

General physical health deterioration

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

2 / 153 (1.31%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Multiple organ dysfunction syndrome

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

1 / 31 (3.23%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (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

0 / 1

0 / 0

Non-cardiac chest pain

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Oedema peripheral

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pain

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (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 / 46 (0.00%)

0 / 39 (0.00%)

3 / 31 (9.68%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 21 (4.76%)

1 / 20 (5.00%)

0 / 5 (0.00%)

1 / 11 (9.09%)

3 / 153 (1.96%)

3 / 78 (3.85%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

2 / 4

0 / 0

0 / 1

0 / 0

0 / 1

0 / 6

2 / 4

0 / 0

deaths causally related to treatment / all

0 / 0

Systemic inflammatory response syndrome

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Immune system disorders

Drug hypersensitivity

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Social circumstances

Social stay hospitalisation

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Reproductive system and breast disorders

Cystocele

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Female genital tract fistula

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (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 promyelocytic leukaemia differentiation syndrome

subjects affected / exposed

4 / 46 (8.70%)

2 / 39 (5.13%)

2 / 31 (6.45%)

1 / 16 (6.25%)

2 / 10 (20.00%)

1 / 20 (5.00%)

2 / 21 (9.52%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

14 / 153 (9.15%)

6 / 78 (7.69%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

3 / 4

2 / 2

0 / 2

0 / 1

2 / 2

1 / 1

1 / 2

0 / 0

12 / 16

3 / 6

0 / 0

deaths causally related to treatment / all

0 / 0

1 / 1

0 / 0

Acute respiratory distress syndrome

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (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

Acute respiratory failure

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

1 / 31 (3.23%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (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

Bronchopneumopathy

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

1 / 20 (5.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Epistaxis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (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

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

1 / 11 (9.09%)

1 / 153 (0.65%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Laryngeal oedema

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lung disorder

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

1 / 20 (5.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (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

Pharyngeal haemorrhage

subjects affected / exposed

1 / 46 (2.17%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pleural effusion

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

2 / 153 (1.31%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 2

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Pneumonitis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (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 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pulmonary haemorrhage

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pulmonary oedema

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory alkalosis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

1 / 5 (20.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory failure

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

2 / 153 (1.31%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 2

0 / 0

Psychiatric disorders

Acute psychosis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Catatonia

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Confusional state

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Delirium

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Depression

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Mental status changes

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

1 / 31 (3.23%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (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

Investigations

Electrocardiogram QT prolonged

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

1 / 20 (5.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gamma-glutamyltransferase increased

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

1 / 20 (5.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatic enzyme increased

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

4 / 153 (2.61%)

0 / 78 (0.00%)

1 / 18 (5.56%)

occurrences causally related to treatment / all

0 / 0

5 / 5

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Lipase increased

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

1 / 18 (5.56%)

occurrences causally related to treatment / all

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Liver function test abnormal

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

2 / 11 (18.18%)

2 / 153 (1.31%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 3

2 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Liver function test increased

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

2 / 153 (1.31%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Neutrophil count decreased

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

2 / 153 (1.31%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Platelet count decreased

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

1 / 31 (3.23%)

0 / 16 (0.00%)

1 / 10 (10.00%)

1 / 20 (5.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

2 / 78 (2.56%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 2

0 / 1

0 / 0

0 / 1

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Red blood cell count decreased

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

1 / 31 (3.23%)

1 / 16 (6.25%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

1 / 20 (5.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (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

Transaminases increased

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

White blood cell count increased

subjects affected / exposed

5 / 46 (10.87%)

3 / 39 (7.69%)

5 / 31 (16.13%)

2 / 16 (12.50%)

1 / 10 (10.00%)

1 / 20 (5.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

1 / 5 (20.00%)

1 / 11 (9.09%)

6 / 153 (3.92%)

10 / 78 (12.82%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

3 / 5

2 / 3

1 / 6

0 / 2

0 / 1

0 / 0

0 / 1

1 / 1

3 / 6

4 / 11

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Ankle fracture

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Fall

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

1 / 18 (5.56%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Femoral neck fracture

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infusion related reaction

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Laceration

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lower limb fracture

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lumbar vertebral fracture

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

1 / 11 (9.09%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Subdural haematoma

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

1 / 31 (3.23%)

1 / 16 (6.25%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

2 / 78 (2.56%)

1 / 18 (5.56%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 2

1 / 1

deaths causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 2

0 / 0

Subarachnoid haemorrhage

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Congenital, familial and genetic disorders

Familial mediterranean fever

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

1 / 10 (10.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Acute coronary syndrome

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

1 / 11 (9.09%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Atrial flutter

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

1 / 20 (5.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (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 fibrillation

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

1 / 31 (3.23%)

1 / 16 (6.25%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 21 (4.76%)

2 / 20 (10.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

2 / 78 (2.56%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

1 / 1

0 / 3

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Atrioventricular block

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (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

Cardiac arrest

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

1 / 31 (3.23%)

0 / 16 (0.00%)

0 / 10 (0.00%)

1 / 20 (5.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

2 / 78 (2.56%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

Cardiac failure

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac failure congestive

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (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

Coronary artery disease

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Coronary artery stenosis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Myocardial infarction

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pericardial effusion

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

1 / 11 (9.09%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Supraventricular tachycardia

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

1 / 31 (3.23%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

1 / 78 (1.28%)

0 / 18 (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

Ventricular extrasystoles

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nervous system disorders

Cerebral haemorrhage

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

1 / 31 (3.23%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

3 / 153 (1.96%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 3

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 1

0 / 0

Cerebral infarction

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cerebrovascular accident

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

1 / 5 (20.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Dizziness

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

1 / 31 (3.23%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (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

Encephalopathy

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

1 / 31 (3.23%)

1 / 16 (6.25%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (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

Haemorrhagic stroke

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

Haemorrhage intracranial

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

2 / 153 (1.31%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

1 / 1

0 / 0

0 / 2

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Polyneuropathy

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Seizure

subjects affected / exposed

1 / 46 (2.17%)

0 / 39 (0.00%)

1 / 31 (3.23%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

2 / 78 (2.56%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Syncope

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

1 / 5 (20.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (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

Blood and lymphatic system disorders

Bone marrow failure

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Disseminated intravascular coagulation

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Febrile neutropenia

subjects affected / exposed

10 / 46 (21.74%)

8 / 39 (20.51%)

6 / 31 (19.35%)

3 / 16 (18.75%)

2 / 10 (20.00%)

2 / 20 (10.00%)

4 / 21 (19.05%)

2 / 20 (10.00%)

2 / 5 (40.00%)

2 / 11 (18.18%)

23 / 153 (15.03%)

16 / 78 (20.51%)

1 / 18 (5.56%)

occurrences causally related to treatment / all

1 / 15

1 / 12

0 / 7

0 / 3

0 / 2

1 / 4

1 / 8

1 / 2

0 / 3

0 / 2

2 / 28

1 / 22

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Febrile bone marrow aplasia

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 5 (0.00%)

1 / 11 (9.09%)

3 / 153 (1.96%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

0 / 5

0 / 0

deaths causally related to treatment / all

0 / 0

Haemolytic anaemia

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pancytopenia

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (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 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

1 / 10 (10.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Anal fistula

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Colitis microscopic

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Colitis ischaemic

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Colitis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

1 / 10 (10.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (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

Constipation

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

1 / 20 (5.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Diarrhoea

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

2 / 153 (1.31%)

1 / 78 (1.28%)

1 / 18 (5.56%)

occurrences causally related to treatment / all

0 / 1

0 / 0

1 / 2

0 / 1

deaths causally related to treatment / all

0 / 0

Gastrointestinal angiectasia

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal fistula

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

Gastrointestinal haemorrhage

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

1 / 5 (20.00%)

0 / 11 (0.00%)

2 / 153 (1.31%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Large intestinal obstruction

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

Large intestine perforation

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lower gastrointestinal haemorrhage

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

2 / 153 (1.31%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 2

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nausea

subjects affected / exposed

2 / 46 (4.35%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

1 / 20 (5.00%)

0 / 21 (0.00%)

1 / 20 (5.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

2 / 78 (2.56%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 1

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Rectal haemorrhage

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

1 / 31 (3.23%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (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

Upper gastrointestinal haemorrhage

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vomiting

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

1 / 20 (5.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

Biliary tract disorder

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cholangitis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cholecystitis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cholelithiasis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

1 / 31 (3.23%)

1 / 16 (6.25%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (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

Gallbladder obstruction

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gallbladder perforation

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatitis acute

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

1 / 18 (5.56%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Skin and subcutaneous tissue disorders

Acute febrile neutrophilic dermatosis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

2 / 153 (1.31%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Angioedema

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

1 / 10 (10.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pruritus

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pyoderma gangrenosum

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

1 / 18 (5.56%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Skin mass

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

Acute kidney injury

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

1 / 10 (10.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

2 / 153 (1.31%)

2 / 78 (2.56%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

Renal failure

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal colic

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

Arthritis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Back pain

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

2 / 153 (1.31%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 2

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Bone pain

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (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

Flank pain

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

1 / 31 (3.23%)

1 / 16 (6.25%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (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

Muscle haemorrhage

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

1 / 31 (3.23%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (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

Musculoskeletal pain

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

1 / 31 (3.23%)

1 / 16 (6.25%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (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

Osteoarthritis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (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

Anal abscess

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

1 / 31 (3.23%)

0 / 16 (0.00%)

0 / 10 (0.00%)

1 / 20 (5.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

1 / 1

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Anorectal infection

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Aspergillus infection

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

1 / 11 (9.09%)

2 / 153 (1.31%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Bacteraemia

subjects affected / exposed

1 / 46 (2.17%)

0 / 39 (0.00%)

1 / 31 (3.23%)

1 / 16 (6.25%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

2 / 78 (2.56%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 2

0 / 0

0 / 1

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

Bacterial prostatitis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

1 / 20 (5.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Bacterial sepsis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Bronchopulmonary aspergillosis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

1 / 11 (9.09%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cellulitis

subjects affected / exposed

2 / 46 (4.35%)

2 / 39 (5.13%)

1 / 31 (3.23%)

0 / 16 (0.00%)

0 / 10 (0.00%)

2 / 20 (10.00%)

0 / 21 (0.00%)

1 / 20 (5.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

3 / 153 (1.96%)

3 / 78 (3.85%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 3

0 / 1

0 / 0

2 / 2

0 / 0

0 / 1

0 / 0

0 / 3

0 / 4

0 / 0

deaths causally related to treatment / all

0 / 0

Clostridium difficile colitis

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

1 / 20 (5.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Clostridial sepsis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Corona virus infection

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

2 / 20 (10.00%)

1 / 21 (4.76%)

1 / 20 (5.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

3 / 153 (1.96%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 1

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Device related infection

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

2 / 153 (1.31%)

0 / 78 (0.00%)

1 / 18 (5.56%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Diverticulitis

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

1 / 31 (3.23%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

2 / 78 (2.56%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Empyema

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Enterococcal bacteraemia

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

1 / 20 (5.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

1 / 5 (20.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (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

0 / 1

0 / 0

Escherichia infection

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Enterococcal sepsis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

1 / 20 (5.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (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

Escherichia sepsis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

1 / 10 (10.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (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

Gastroenteritis

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Human bocavirus infection

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

1 / 20 (5.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (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

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

2 / 153 (1.31%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 2

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infection

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Klebsiella infection

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

1 / 20 (5.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Labyrinthitis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Laryngitis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Liver abscess

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

1 / 31 (3.23%)

1 / 16 (6.25%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

1 / 78 (1.28%)

0 / 18 (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

Lower respiratory tract infection fungal

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (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

Lower respiratory tract infection

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Mucosal infection

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Mucormycosis

subjects affected / exposed

1 / 46 (2.17%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metapneumovirus infection

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Neutropenic sepsis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Parotitis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Parainfluenzae virus infection

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Periorbital cellulitis

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia

subjects affected / exposed

7 / 46 (15.22%)

5 / 39 (12.82%)

7 / 31 (22.58%)

2 / 16 (12.50%)

1 / 10 (10.00%)

1 / 20 (5.00%)

4 / 21 (19.05%)

2 / 20 (10.00%)

1 / 5 (20.00%)

0 / 11 (0.00%)

14 / 153 (9.15%)

14 / 78 (17.95%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

1 / 8

1 / 6

0 / 10

0 / 2

0 / 1

0 / 5

0 / 2

0 / 0

0 / 14

1 / 18

0 / 0

deaths causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 2

0 / 0

0 / 3

0 / 2

0 / 0

Pneumonia legionella

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

1 / 11 (9.09%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia fungal

subjects affected / exposed

2 / 46 (4.35%)

2 / 39 (5.13%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

3 / 153 (1.96%)

2 / 78 (2.56%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 0

0 / 3

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 2

0 / 0

Pneumonia mycoplasmal

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia pseudomonal

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

1 / 20 (5.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia pneumococcal

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pseudomonal sepsis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

1 / 20 (5.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Pulmonary mycosis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (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

Pulmonary sepsis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rectal abscess

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory tract infection

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

1 / 11 (9.09%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rhinovirus infection

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Septic shock

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

2 / 31 (6.45%)

2 / 16 (12.50%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

2 / 153 (1.31%)

3 / 78 (3.85%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 2

0 / 0

0 / 2

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 2

0 / 0

Sepsis

subjects affected / exposed

2 / 46 (4.35%)

2 / 39 (5.13%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

3 / 21 (14.29%)

1 / 20 (5.00%)

0 / 5 (0.00%)

2 / 11 (18.18%)

6 / 153 (3.92%)

2 / 78 (2.56%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 3

0 / 0

0 / 3

0 / 1

0 / 0

0 / 2

0 / 7

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 2

0 / 0

Skin infection

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (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

Soft tissue infection

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Staphylococcal bacteraemia

subjects affected / exposed

1 / 46 (2.17%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

1 / 20 (5.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Staphylococcal infection

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

1 / 20 (5.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

2 / 153 (1.31%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Staphylococcal skin infection

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Streptococcal sepsis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Tooth infection

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

2 / 153 (1.31%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Upper respiratory tract infection

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

1 / 31 (3.23%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

1 / 78 (1.28%)

0 / 18 (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

Urosepsis

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Urinary tract infection

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

1 / 31 (3.23%)

0 / 16 (0.00%)

1 / 10 (10.00%)

1 / 20 (5.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

1 / 5 (20.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

2 / 78 (2.56%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 1

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Viral infection

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

1 / 20 (5.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

0 / 78 (0.00%)

0 / 18 (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

Decreased appetite

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

1 / 10 (10.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (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

Dehydration

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

1 / 21 (4.76%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (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

Failure to thrive

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

1 / 1

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gout

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypokalaemia

subjects affected / exposed

1 / 46 (2.17%)

1 / 39 (2.56%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 153 (0.00%)

1 / 78 (1.28%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Tumour lysis syndrome

subjects affected / exposed

0 / 46 (0.00%)

0 / 39 (0.00%)

0 / 31 (0.00%)

0 / 16 (0.00%)

0 / 10 (0.00%)

0 / 20 (0.00%)

0 / 21 (0.00%)

0 / 20 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 153 (0.65%)

0 / 78 (0.00%)

0 / 18 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

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

Non-serious adverse events	Phase 1:TotalFT-2102;FT-2102+azacitidine(Combination Therapy)	Phase 1: FT-2102+azacitidine(Combination Therapy)	Phase 1: Total FT-2102 (Single Agent)	Phase 1: FT-2102 (Single Agent)	Phase 2: Cohort 7; FT-2102 (Single Agent)	Phase 2: Cohort 4; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 5; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 6; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 3; FT-2102 (Single Agent)	Phase 2: Cohort 8; FT-2102+azacitidine (Combination Therapy)	Phase 2: Cohort 1; FT-2102 (Single Agent)	Phase 1: Overall	Phase 2: Cohort 2; FT-2102 (Single Agent)
Total subjects affected by non serious adverse events
subjects affected / exposed	46 / 46 (100.00%)	39 / 39 (100.00%)	29 / 31 (93.55%)	15 / 16 (93.75%)	10 / 10 (100.00%)	18 / 20 (90.00%)	20 / 21 (95.24%)	19 / 20 (95.00%)	5 / 5 (100.00%)	11 / 11 (100.00%)	152 / 153 (99.35%)	76 / 78 (97.44%)	18 / 18 (100.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Basal cell carcinoma
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	0	0	1	0	0	0	0	4	1	0
Cancer pain
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	1	0
Endotheliomatosis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Melanocytic naevus
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	2 / 18 (11.11%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	2
Squamous cell carcinoma of skin
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	1 / 18 (5.56%)
occurrences all number	2	2	0	0	0	1	0	0	0	0	0	2	1
Vascular disorders
Aortic calcification
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0
Deep vein thrombosis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	0	2	0	0	1	1	0	1	1	0
Embolism
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0
Flushing
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	1	0
Haematoma
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	3 / 31 (9.68%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	3 / 11 (27.27%)	2 / 153 (1.31%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	1	1	4	0	0	0	0	0	0	3	4	5	0
Hypertension
subjects affected / exposed	9 / 46 (19.57%)	7 / 39 (17.95%)	5 / 31 (16.13%)	3 / 16 (18.75%)	2 / 10 (20.00%)	4 / 20 (20.00%)	1 / 21 (4.76%)	2 / 20 (10.00%)	0 / 5 (0.00%)	2 / 11 (18.18%)	17 / 153 (11.11%)	14 / 78 (17.95%)	0 / 18 (0.00%)
occurrences all number	15	9	5	3	2	6	1	4	0	3	31	20	0
Hypertensive crisis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0
Hypotension
subjects affected / exposed	5 / 46 (10.87%)	5 / 39 (12.82%)	4 / 31 (12.90%)	2 / 16 (12.50%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	2 / 5 (40.00%)	2 / 11 (18.18%)	7 / 153 (4.58%)	9 / 78 (11.54%)	0 / 18 (0.00%)
occurrences all number	5	5	5	2	0	1	1	0	2	3	8	10	0
Orthostatic hypotension
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	1	1	0	1	0
Thrombophlebitis superficial
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	1
Thrombosis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0
Venous thrombosis limb
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0
General disorders and administration site conditions
Administration site pain
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Asthenia
subjects affected / exposed	11 / 46 (23.91%)	10 / 39 (25.64%)	1 / 31 (3.23%)	0 / 16 (0.00%)	1 / 10 (10.00%)	2 / 20 (10.00%)	3 / 21 (14.29%)	3 / 20 (15.00%)	1 / 5 (20.00%)	4 / 11 (36.36%)	30 / 153 (19.61%)	12 / 78 (15.38%)	2 / 18 (11.11%)
occurrences all number	15	14	1	0	2	2	13	4	3	11	49	16	2
Catheter site bruise
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0
Catheter site rash
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	1	0	1	0
Catheter site pain
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	3 / 78 (3.85%)	0 / 18 (0.00%)
occurrences all number	2	2	0	0	0	0	0	0	0	0	0	3	0
Catheter site haemorrhage
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	1	0	3	0	0	0
Chest discomfort
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	2	1	0
Chills
subjects affected / exposed	6 / 46 (13.04%)	6 / 39 (15.38%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	2 / 20 (10.00%)	2 / 21 (9.52%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	6 / 153 (3.92%)	7 / 78 (8.97%)	0 / 18 (0.00%)
occurrences all number	10	10	1	0	0	2	2	0	0	1	6	11	0
Device related thrombosis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	1	0
Drug intolerance
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0
Early satiety
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	1	1	0	1	0
Fatigue
subjects affected / exposed	19 / 46 (41.30%)	16 / 39 (41.03%)	13 / 31 (41.94%)	6 / 16 (37.50%)	2 / 10 (20.00%)	6 / 20 (30.00%)	6 / 21 (28.57%)	7 / 20 (35.00%)	2 / 5 (40.00%)	0 / 11 (0.00%)	35 / 153 (22.88%)	32 / 78 (41.03%)	6 / 18 (33.33%)
occurrences all number	28	25	16	9	2	6	7	11	2	0	47	44	8
Facial pain
subjects affected / exposed	1 / 46 (2.17%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	2	0	0	0	0	1	0	0	0	0	1	2	0
Generalised oedema
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	2 / 153 (1.31%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	1	1	1	0	0	0	0	0	0	1	2	2	0
General physical health deterioration
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	2 / 20 (10.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	1	0	0	0
Injection site erythema
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	1	1	0	0	0	2	0	0	0	0	0	1	0
Influenza like illness
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	3	0	0
Injection site pain
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	2 / 20 (10.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	2	2	0	0	0	1	0	2	0	0	0	2	0
Injection site reaction
subjects affected / exposed	3 / 46 (6.52%)	3 / 39 (7.69%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	2 / 20 (10.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	2 / 11 (18.18%)	0 / 153 (0.00%)	3 / 78 (3.85%)	0 / 18 (0.00%)
occurrences all number	4	4	0	0	0	2	0	1	0	2	0	4	0
Malaise
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	3 / 20 (15.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	4 / 153 (2.61%)	3 / 78 (3.85%)	1 / 18 (5.56%)
occurrences all number	2	2	1	0	0	3	0	1	0	0	5	3	1
Mucosal dryness
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Oedema peripheral
subjects affected / exposed	10 / 46 (21.74%)	8 / 39 (20.51%)	1 / 31 (3.23%)	0 / 16 (0.00%)	5 / 10 (50.00%)	3 / 20 (15.00%)	4 / 21 (19.05%)	4 / 20 (20.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	23 / 153 (15.03%)	12 / 78 (15.38%)	2 / 18 (11.11%)
occurrences all number	12	10	1	0	5	3	4	5	0	3	36	14	2
Non-cardiac chest pain
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	7 / 153 (4.58%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	2	2	0	0	0	0	0	0	0	1	10	2	0
Pain
subjects affected / exposed	4 / 46 (8.70%)	3 / 39 (7.69%)	2 / 31 (6.45%)	1 / 16 (6.25%)	2 / 10 (20.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	6 / 153 (3.92%)	6 / 78 (7.69%)	1 / 18 (5.56%)
occurrences all number	4	3	3	2	2	0	1	2	0	0	9	7	1
Peripheral swelling
subjects affected / exposed	7 / 46 (15.22%)	7 / 39 (17.95%)	1 / 31 (3.23%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	9 / 78 (11.54%)	0 / 18 (0.00%)
occurrences all number	9	9	1	0	1	0	1	0	0	0	0	12	0
Pyrexia
subjects affected / exposed	11 / 46 (23.91%)	9 / 39 (23.08%)	9 / 31 (29.03%)	4 / 16 (25.00%)	3 / 10 (30.00%)	5 / 20 (25.00%)	1 / 21 (4.76%)	2 / 20 (10.00%)	1 / 5 (20.00%)	3 / 11 (27.27%)	35 / 153 (22.88%)	20 / 78 (25.64%)	0 / 18 (0.00%)
occurrences all number	16	14	12	5	5	9	2	3	1	3	53	28	0
Systemic inflammatory response syndrome
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	1	0
Temperature intolerance
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Vessel puncture site bruise
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	1	1	0	0	0	0	0
Immune system disorders
Drug hypersensitivity
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0	0	0	1	0	0
Hypogammaglobulinaemia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0
Seasonal allergy
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	1	1	1	0	0	0	0	1	0	0	0	2	0
Reproductive system and breast disorders
Breast haemorrhage
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0
Breast mass
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1
Genital erythema
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0
Pelvic pain
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	1	1	0	0	0	0	0	1	0	0	0	1	0
Vulvovaginal pain
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	2	2	0	0	0	0	0	0	0	0	0	2	0
Vulvovaginal dryness
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Acute promyelocytic leukaemia differentiation syndrome
subjects affected / exposed	4 / 46 (8.70%)	4 / 39 (10.26%)	2 / 31 (6.45%)	2 / 16 (12.50%)	0 / 10 (0.00%)	2 / 20 (10.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	2 / 5 (40.00%)	1 / 11 (9.09%)	11 / 153 (7.19%)	6 / 78 (7.69%)	0 / 18 (0.00%)
occurrences all number	5	5	2	2	0	2	0	0	2	1	11	7	0
Catarrh
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0
Cough
subjects affected / exposed	18 / 46 (39.13%)	15 / 39 (38.46%)	5 / 31 (16.13%)	3 / 16 (18.75%)	4 / 10 (40.00%)	4 / 20 (20.00%)	4 / 21 (19.05%)	3 / 20 (15.00%)	1 / 5 (20.00%)	3 / 11 (27.27%)	25 / 153 (16.34%)	23 / 78 (29.49%)	3 / 18 (16.67%)
occurrences all number	19	16	5	3	5	5	5	3	1	3	33	24	3
Dyspnoea
subjects affected / exposed	13 / 46 (28.26%)	12 / 39 (30.77%)	7 / 31 (22.58%)	4 / 16 (25.00%)	2 / 10 (20.00%)	2 / 20 (10.00%)	1 / 21 (4.76%)	3 / 20 (15.00%)	2 / 5 (40.00%)	2 / 11 (18.18%)	31 / 153 (20.26%)	20 / 78 (25.64%)	2 / 18 (11.11%)
occurrences all number	23	22	8	5	3	2	1	4	2	2	50	31	3
Dyspnoea exertional
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	1 / 5 (20.00%)	1 / 11 (9.09%)	1 / 153 (0.65%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	1	1	1	0	0	1	1	0	1	1	1	2	0
Dyspnoea paroxysmal nocturnal
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	1 / 18 (5.56%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	1	1
Epistaxis
subjects affected / exposed	7 / 46 (15.22%)	7 / 39 (17.95%)	5 / 31 (16.13%)	2 / 16 (12.50%)	1 / 10 (10.00%)	4 / 20 (20.00%)	4 / 21 (19.05%)	1 / 20 (5.00%)	1 / 5 (20.00%)	3 / 11 (27.27%)	17 / 153 (11.11%)	12 / 78 (15.38%)	0 / 18 (0.00%)
occurrences all number	8	8	6	3	1	4	4	1	1	8	32	14	0
Haemoptysis
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	1 / 5 (20.00%)	1 / 11 (9.09%)	4 / 153 (2.61%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	1	1	0	0	0	0	1	0	1	1	4	1	0
Hiccups
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	2	0	0	0
Hypoxia
subjects affected / exposed	2 / 46 (4.35%)	1 / 39 (2.56%)	2 / 31 (6.45%)	1 / 16 (6.25%)	1 / 10 (10.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	4 / 153 (2.61%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	2	1	2	1	1	1	0	0	0	0	7	4	0
Nasal septum perforation
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0
Nasal dryness
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	1	1	1	1	0	0	0	0	0	0	0	2	0
Nasal congestion
subjects affected / exposed	4 / 46 (8.70%)	3 / 39 (7.69%)	2 / 31 (6.45%)	2 / 16 (12.50%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	6 / 78 (7.69%)	0 / 18 (0.00%)
occurrences all number	4	3	2	2	0	0	1	0	0	0	1	6	0
Oropharyngeal pain
subjects affected / exposed	7 / 46 (15.22%)	5 / 39 (12.82%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 21 (4.76%)	2 / 20 (10.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	5 / 153 (3.27%)	7 / 78 (8.97%)	1 / 18 (5.56%)
occurrences all number	8	6	0	0	0	1	1	2	1	0	5	8	1
Pleural effusion
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	3 / 31 (9.68%)	2 / 16 (12.50%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	5 / 78 (6.41%)	0 / 18 (0.00%)
occurrences all number	2	2	3	2	0	1	0	0	1	0	1	5	0
Pleuritic pain
subjects affected / exposed	2 / 46 (4.35%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	2 / 153 (1.31%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0	1	2	2	0
Pneumonitis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0
Productive cough
subjects affected / exposed	2 / 46 (4.35%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	5 / 153 (3.27%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	2	1	0	0	0	1	0	0	0	0	5	2	0
Pulmonary oedema
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	4 / 153 (2.61%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	0	1	0	0	0	0	0	4	1	0
Pulmonary embolism
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	2	0	1
Rales
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	1 / 153 (0.65%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	1	1	1	0
Rhinorrhoea
subjects affected / exposed	5 / 46 (10.87%)	5 / 39 (12.82%)	3 / 31 (9.68%)	3 / 16 (18.75%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	8 / 78 (10.26%)	1 / 18 (5.56%)
occurrences all number	6	6	3	3	0	0	1	0	0	0	2	9	1
Sinus pain
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	1 / 18 (5.56%)
occurrences all number	1	1	0	0	0	1	0	0	0	0	0	1	1
Sneezing
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	1	0
Sputum discoloured
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0
Tachypnoea
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	1	0	0
Upper-airway cough syndrome
subjects affected / exposed	3 / 46 (6.52%)	3 / 39 (7.69%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	4	4	1	0	0	0	0	0	0	0	0	5	0
Wheezing
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	1	0	0	0	0	1	0
Psychiatric disorders
Affective disorder
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Agitation
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	3 / 153 (1.96%)	2 / 78 (2.56%)	1 / 18 (5.56%)
occurrences all number	2	2	0	0	0	0	0	0	0	1	3	2	1
Anxiety
subjects affected / exposed	6 / 46 (13.04%)	5 / 39 (12.82%)	2 / 31 (6.45%)	1 / 16 (6.25%)	1 / 10 (10.00%)	2 / 20 (10.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 5 (0.00%)	2 / 11 (18.18%)	7 / 153 (4.58%)	9 / 78 (11.54%)	0 / 18 (0.00%)
occurrences all number	6	5	2	1	2	2	1	1	0	4	7	9	0
Confusional state
subjects affected / exposed	3 / 46 (6.52%)	3 / 39 (7.69%)	2 / 31 (6.45%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	6 / 153 (3.92%)	5 / 78 (6.41%)	0 / 18 (0.00%)
occurrences all number	3	3	3	0	1	0	0	0	1	0	7	6	0
Delirium
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	3 / 153 (1.96%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	1	1	0	0	0	2	0	0	0	0	3	1	0
Depression
subjects affected / exposed	4 / 46 (8.70%)	4 / 39 (10.26%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	2 / 20 (10.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	6 / 153 (3.92%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	5	5	0	0	0	2	1	0	0	0	8	5	0
Flat affect
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0
Insomnia
subjects affected / exposed	7 / 46 (15.22%)	5 / 39 (12.82%)	6 / 31 (19.35%)	4 / 16 (25.00%)	0 / 10 (0.00%)	4 / 20 (20.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	2 / 11 (18.18%)	12 / 153 (7.84%)	13 / 78 (16.67%)	3 / 18 (16.67%)
occurrences all number	8	6	6	4	0	5	1	0	0	6	13	14	3
Mental disorder
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1
Mental status changes
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	3 / 31 (9.68%)	2 / 16 (12.50%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	2 / 5 (40.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	1	1	3	2	0	0	0	0	3	0	2	4	0
Restlessness
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	7 / 46 (15.22%)	6 / 39 (15.38%)	3 / 31 (9.68%)	3 / 16 (18.75%)	0 / 10 (0.00%)	0 / 20 (0.00%)	2 / 21 (9.52%)	2 / 20 (10.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	18 / 153 (11.76%)	11 / 78 (14.10%)	2 / 18 (11.11%)
occurrences all number	7	6	9	9	0	0	3	3	1	0	38	17	5
Amylase increased
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	1 / 31 (3.23%)	1 / 16 (6.25%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	7 / 153 (4.58%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	1	1	1	1	1	0	0	1	0	1	8	2	0
Aspartate aminotransferase increased
subjects affected / exposed	5 / 46 (10.87%)	5 / 39 (12.82%)	5 / 31 (16.13%)	4 / 16 (25.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	2 / 21 (9.52%)	1 / 20 (5.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	14 / 153 (9.15%)	11 / 78 (14.10%)	2 / 18 (11.11%)
occurrences all number	8	8	9	8	0	0	2	2	1	0	27	18	3
Blood alkaline phosphatase increased
subjects affected / exposed	6 / 46 (13.04%)	5 / 39 (12.82%)	3 / 31 (9.68%)	2 / 16 (12.50%)	1 / 10 (10.00%)	1 / 20 (5.00%)	1 / 21 (4.76%)	2 / 20 (10.00%)	2 / 5 (40.00%)	0 / 11 (0.00%)	9 / 153 (5.88%)	10 / 78 (12.82%)	1 / 18 (5.56%)
occurrences all number	9	8	6	5	3	1	1	2	2	0	19	16	1
Blood bicarbonate decreased
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Blood bilirubin increased
subjects affected / exposed	3 / 46 (6.52%)	2 / 39 (5.13%)	4 / 31 (12.90%)	4 / 16 (25.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	3 / 21 (14.29%)	1 / 20 (5.00%)	1 / 5 (20.00%)	1 / 11 (9.09%)	8 / 153 (5.23%)	8 / 78 (10.26%)	0 / 18 (0.00%)
occurrences all number	3	2	8	8	1	0	13	1	3	6	10	12	0
Blood creatine increased
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	1	1	0	0	0	1	0	0	0	0	0	1	0
Blood creatinine increased
subjects affected / exposed	6 / 46 (13.04%)	5 / 39 (12.82%)	1 / 31 (3.23%)	1 / 16 (6.25%)	2 / 10 (20.00%)	2 / 20 (10.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	1 / 5 (20.00%)	2 / 11 (18.18%)	14 / 153 (9.15%)	7 / 78 (8.97%)	0 / 18 (0.00%)
occurrences all number	7	6	1	1	2	3	0	1	2	9	15	8	0
Blood fibrinogen decreased
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0
Blood lactate dehydrogenase increased
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	4 / 153 (2.61%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	5	0	1
Blood phosphorus decreased
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	1
Blood urea increased
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0
Blood uric acid increased
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	1
Brain natriuretic peptide increased
subjects affected / exposed	1 / 46 (2.17%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	1	0	0	1	0
Chest X-ray abnormal
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	1	0	1	1	0
Coronavirus test positive
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1
Electrocardiogram QT prolonged
subjects affected / exposed	3 / 46 (6.52%)	3 / 39 (7.69%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	2 / 20 (10.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	1 / 5 (20.00%)	1 / 11 (9.09%)	12 / 153 (7.84%)	3 / 78 (3.85%)	0 / 18 (0.00%)
occurrences all number	4	4	0	0	0	2	0	2	2	1	18	4	0
Ejection fraction decreased
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	2 / 31 (6.45%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	0	0	2	1	0	0	0	0	0	0	0	2	0
Enterococcus test positive
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Gamma-glutamyltransferase increased
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	2 / 21 (9.52%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	11 / 153 (7.19%)	1 / 78 (1.28%)	2 / 18 (11.11%)
occurrences all number	1	1	0	0	0	0	3	1	0	0	24	1	7
Heart rate increased
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0
Hepatic enzyme increased
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	5 / 153 (3.27%)	0 / 78 (0.00%)	2 / 18 (11.11%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	11	0	6
Lipase increased
subjects affected / exposed	4 / 46 (8.70%)	4 / 39 (10.26%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	10 / 153 (6.54%)	5 / 78 (6.41%)	0 / 18 (0.00%)
occurrences all number	6	6	1	1	0	1	0	0	0	1	20	7	0
Liver function test abnormal
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	3	0	0
Liver function test increased
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Lymphocyte count decreased
subjects affected / exposed	5 / 46 (10.87%)	4 / 39 (10.26%)	3 / 31 (9.68%)	2 / 16 (12.50%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	8 / 78 (10.26%)	1 / 18 (5.56%)
occurrences all number	11	5	3	2	0	0	0	5	0	0	1	14	1
Neutrophil count decreased
subjects affected / exposed	14 / 46 (30.43%)	12 / 39 (30.77%)	3 / 31 (9.68%)	0 / 16 (0.00%)	2 / 10 (20.00%)	6 / 20 (30.00%)	5 / 21 (23.81%)	5 / 20 (25.00%)	0 / 5 (0.00%)	3 / 11 (27.27%)	21 / 153 (13.73%)	18 / 78 (23.08%)	4 / 18 (22.22%)
occurrences all number	41	35	5	0	6	7	16	14	0	11	65	47	10
Platelet count decreased
subjects affected / exposed	20 / 46 (43.48%)	18 / 39 (46.15%)	8 / 31 (25.81%)	4 / 16 (25.00%)	1 / 10 (10.00%)	6 / 20 (30.00%)	9 / 21 (42.86%)	4 / 20 (20.00%)	1 / 5 (20.00%)	3 / 11 (27.27%)	31 / 153 (20.26%)	28 / 78 (35.90%)	3 / 18 (16.67%)
occurrences all number	81	67	16	7	7	34	38	32	1	20	152	97	4
Platelet count increased
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	3 / 153 (1.96%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	3	0	1
Red blood cell count decreased
subjects affected / exposed	11 / 46 (23.91%)	8 / 39 (20.51%)	6 / 31 (19.35%)	4 / 16 (25.00%)	2 / 10 (20.00%)	7 / 20 (35.00%)	5 / 21 (23.81%)	5 / 20 (25.00%)	1 / 5 (20.00%)	1 / 11 (9.09%)	40 / 153 (26.14%)	17 / 78 (21.79%)	3 / 18 (16.67%)
occurrences all number	29	26	10	6	5	27	22	26	1	5	123	39	7
Staphylococcus test positive
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Transaminases increased
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	1 / 20 (5.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	2	2	0	0	2	3	1	0	0	0	2	2	0
Weight decreased
subjects affected / exposed	5 / 46 (10.87%)	4 / 39 (10.26%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	2 / 20 (10.00%)	1 / 21 (4.76%)	5 / 20 (25.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	7 / 153 (4.58%)	5 / 78 (6.41%)	0 / 18 (0.00%)
occurrences all number	5	4	0	0	0	4	1	6	0	1	9	5	0
White blood cell count decreased
subjects affected / exposed	8 / 46 (17.39%)	6 / 39 (15.38%)	2 / 31 (6.45%)	1 / 16 (6.25%)	0 / 10 (0.00%)	2 / 20 (10.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	4 / 153 (2.61%)	10 / 78 (12.82%)	1 / 18 (5.56%)
occurrences all number	13	9	2	1	0	2	1	1	0	1	13	15	1
White blood cell count increased
subjects affected / exposed	10 / 46 (21.74%)	8 / 39 (20.51%)	3 / 31 (9.68%)	2 / 16 (12.50%)	0 / 10 (0.00%)	3 / 20 (15.00%)	3 / 21 (14.29%)	4 / 20 (20.00%)	2 / 5 (40.00%)	1 / 11 (9.09%)	36 / 153 (23.53%)	13 / 78 (16.67%)	1 / 18 (5.56%)
occurrences all number	12	10	4	3	0	6	3	6	6	1	56	16	1
Injury, poisoning and procedural complications
Contusion
subjects affected / exposed	5 / 46 (10.87%)	4 / 39 (10.26%)	4 / 31 (12.90%)	2 / 16 (12.50%)	1 / 10 (10.00%)	2 / 20 (10.00%)	1 / 21 (4.76%)	2 / 20 (10.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	6 / 153 (3.92%)	9 / 78 (11.54%)	0 / 18 (0.00%)
occurrences all number	5	4	4	2	1	2	1	3	0	0	8	9	0
Eye contusion
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	1	0
Fall
subjects affected / exposed	5 / 46 (10.87%)	4 / 39 (10.26%)	3 / 31 (9.68%)	2 / 16 (12.50%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	14 / 153 (9.15%)	8 / 78 (10.26%)	1 / 18 (5.56%)
occurrences all number	8	7	4	2	0	1	0	1	0	1	14	12	1
Hand fracture
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0
Infusion related reaction
subjects affected / exposed	2 / 46 (4.35%)	1 / 39 (2.56%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	3 / 78 (3.85%)	0 / 18 (0.00%)
occurrences all number	4	1	1	1	0	0	0	0	0	0	1	5	0
Laceration
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	1 / 31 (3.23%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	2 / 153 (1.31%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	2	2	1	0	1	0	0	0	0	1	2	3	0
Limb injury
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	2 / 153 (1.31%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	2	0	0
Medication error
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	3 / 153 (1.96%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	3	0	0
Periorbital haematoma
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Procedural pain
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	2	0	0	0	1	0	0
Post procedural haemorrhage
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0
Skin abrasion
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	1	0
Skin wound
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	2	2	0	0	0	0	0	0	0	0	2	2	0
Subdural haematoma
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	1	0	1	0	0	0	0	0	0
Transfusion reaction
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	2 / 21 (9.52%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	3 / 153 (1.96%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	1	1	0	0	0	1	3	0	0	0	3	2	0
Wound secretion
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0
Cardiac disorders
Angina pectoris
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	1 / 31 (3.23%)	1 / 16 (6.25%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	1	1	1	1	1	0	0	0	0	0	2	2	0
Arrhythmia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	2 / 31 (6.45%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	2	0
Atrial fibrillation
subjects affected / exposed	5 / 46 (10.87%)	5 / 39 (12.82%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	5 / 153 (3.27%)	6 / 78 (7.69%)	1 / 18 (5.56%)
occurrences all number	5	5	1	0	0	1	2	0	0	1	7	6	1
Atrioventricular block first degree
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	0	1
Atrial tachycardia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	1 / 153 (0.65%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	1	0	0
Atrial flutter
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	3 / 153 (1.96%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	1	0	0	1	0	1	4	0	0
Bradycardia
subjects affected / exposed	3 / 46 (6.52%)	3 / 39 (7.69%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	2 / 153 (1.31%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	3	3	0	0	0	0	0	0	0	1	2	4	0
Cardiac failure
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	1 / 153 (0.65%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	2	1	1	0
Coronary artery disease
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0
Left ventricular dysfunction
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Myocardial ischaemia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0
Palpitations
subjects affected / exposed	5 / 46 (10.87%)	5 / 39 (12.82%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	5 / 153 (3.27%)	5 / 78 (6.41%)	1 / 18 (5.56%)
occurrences all number	5	5	0	0	0	1	0	0	0	0	6	5	1
Pericardial effusion
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	2 / 31 (6.45%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	2	2	2	0	0	0	0	0	0	0	0	4	0
Sinus bradycardia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	1	1	0
Sinus tachycardia
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	1 / 11 (9.09%)	2 / 153 (1.31%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	3	3	0	0	0	1	0	0	1	1	2	3	0
Supraventricular tachycardia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0
Tachycardia
subjects affected / exposed	3 / 46 (6.52%)	3 / 39 (7.69%)	5 / 31 (16.13%)	3 / 16 (18.75%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	5 / 153 (3.27%)	8 / 78 (10.26%)	0 / 18 (0.00%)
occurrences all number	4	4	6	3	0	2	0	0	0	0	6	10	0
Ventricular tachycardia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0
Nervous system disorders
Ageusia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0
Amnesia
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	2	2	0	0	0	0	0	0	0	0	0	2	0
Disturbance in attention
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	1	0
Dizziness
subjects affected / exposed	11 / 46 (23.91%)	11 / 39 (28.21%)	7 / 31 (22.58%)	3 / 16 (18.75%)	2 / 10 (20.00%)	1 / 20 (5.00%)	4 / 21 (19.05%)	2 / 20 (10.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	10 / 153 (6.54%)	18 / 78 (23.08%)	1 / 18 (5.56%)
occurrences all number	16	16	10	5	2	1	4	2	0	2	11	26	1
Dysgeusia
subjects affected / exposed	6 / 46 (13.04%)	5 / 39 (12.82%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	2 / 20 (10.00%)	2 / 21 (9.52%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	7 / 153 (4.58%)	7 / 78 (8.97%)	0 / 18 (0.00%)
occurrences all number	6	5	1	1	0	5	3	0	1	0	7	7	0
Essential tremor
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0
Headache
subjects affected / exposed	15 / 46 (32.61%)	13 / 39 (33.33%)	6 / 31 (19.35%)	1 / 16 (6.25%)	3 / 10 (30.00%)	6 / 20 (30.00%)	3 / 21 (14.29%)	1 / 20 (5.00%)	0 / 5 (0.00%)	2 / 11 (18.18%)	20 / 153 (13.07%)	21 / 78 (26.92%)	6 / 18 (33.33%)
occurrences all number	22	20	7	1	3	9	3	1	0	3	27	29	6
Hyperaesthesia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1
Hypersomnia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0
Hypoaesthesia
subjects affected / exposed	3 / 46 (6.52%)	3 / 39 (7.69%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	3	3	1	1	0	0	1	1	0	0	0	4	0
Lethargy
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 5 (0.00%)	2 / 11 (18.18%)	0 / 153 (0.00%)	2 / 78 (2.56%)	1 / 18 (5.56%)
occurrences all number	1	1	1	0	0	0	1	1	0	2	0	2	1
Memory impairment
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	1 / 78 (1.28%)	1 / 18 (5.56%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	1	1	1
Motor dysfunction
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	3	0	0	0
Neuralgia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Neuropathy peripheral
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	1	1	1	1	0	0	0	0	0	1	0	2	0
Paraesthesia
subjects affected / exposed	2 / 46 (4.35%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	2 / 21 (9.52%)	1 / 20 (5.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	3 / 153 (1.96%)	2 / 78 (2.56%)	1 / 18 (5.56%)
occurrences all number	2	1	0	0	0	1	2	1	0	1	3	2	1
Peripheral sensory neuropathy
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	3 / 153 (1.96%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	3	0	1
Presyncope
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	0	0	0	1	0	2	0	0	1	0
Restless legs syndrome
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	1
Somnolence
subjects affected / exposed	3 / 46 (6.52%)	3 / 39 (7.69%)	2 / 31 (6.45%)	1 / 16 (6.25%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	5 / 78 (6.41%)	0 / 18 (0.00%)
occurrences all number	3	3	2	1	0	1	0	0	0	0	1	5	0
Syncope
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	1 / 5 (20.00%)	1 / 11 (9.09%)	2 / 153 (1.31%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	1	0	1	1	1	1	2	0	0
Tremor
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	2 / 31 (6.45%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	3 / 78 (3.85%)	0 / 18 (0.00%)
occurrences all number	1	1	3	0	0	0	0	0	0	1	0	4	0
Visual field defect
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	2
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1
Bone marrow failure
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Coagulopathy
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	2	2	0	0	0	0	0	0	0	0	0	2	0
Disseminated intravascular coagulation
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	3 / 153 (1.96%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	1	0	1	0	0	1	3	0	0
Eosinophilia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	2
Febrile neutropenia
subjects affected / exposed	5 / 46 (10.87%)	5 / 39 (12.82%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	12 / 153 (7.84%)	6 / 78 (7.69%)	1 / 18 (5.56%)
occurrences all number	7	7	1	0	0	0	0	1	0	1	13	8	1
Febrile bone marrow aplasia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0	0	1	0	0
Haemorrhagic diathesis
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	1 / 153 (0.65%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	3	1	1	0
Lymphadenopathy
subjects affected / exposed	3 / 46 (6.52%)	3 / 39 (7.69%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	3 / 78 (3.85%)	0 / 18 (0.00%)
occurrences all number	3	3	0	0	0	0	0	0	0	0	2	3	0
Splenomegaly
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	2 / 21 (9.52%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	1	1	0	0	0	0	2	0	0	0	2	1	0
Thrombotic thrombocytopenic purpura
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0
Ear and labyrinth disorders
Ear pain
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	4 / 153 (2.61%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	0	1	0	0	4	1	0
Tinnitus
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	1 / 18 (5.56%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	1	1
Vertigo
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	4 / 153 (2.61%)	1 / 78 (1.28%)	1 / 18 (5.56%)
occurrences all number	1	1	0	0	0	0	0	1	0	0	5	1	1
Eye disorders
Cataract
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	2 / 31 (6.45%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	3 / 153 (1.96%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	0	0	2	1	0	0	0	0	0	0	3	2	0
Chalazion
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	1	0	0	0	0
Conjunctival haemorrhage
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	1 / 153 (0.65%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	2	2	0	0	0	0	1	0	0	1	1	2	0
Dry eye
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	2 / 31 (6.45%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	0	0	2	0	0	1	0	0	0	0	0	2	0
Eye haemorrhage
subjects affected / exposed	1 / 46 (2.17%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	2 / 78 (2.56%)	1 / 18 (5.56%)
occurrences all number	1	0	1	1	0	0	1	0	0	0	0	2	1
Eyelid ptosis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0
Eye oedema
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Macular fibrosis
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	1 / 18 (5.56%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	1	3
Ocular hyperaemia
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	2	2	0	0	0	0	1	0	0	0	3	2	0
Vision blurred
subjects affected / exposed	3 / 46 (6.52%)	2 / 39 (5.13%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	3	2	1	0	0	0	0	0	0	0	2	4	0
Visual acuity reduced
subjects affected / exposed	1 / 46 (2.17%)	0 / 39 (0.00%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	2 / 78 (2.56%)	1 / 18 (5.56%)
occurrences all number	1	0	1	0	0	0	1	0	0	0	2	2	1
Visual impairment
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	1	0	0	1	0	0
Gastrointestinal disorders
Abdominal distension
subjects affected / exposed	4 / 46 (8.70%)	3 / 39 (7.69%)	5 / 31 (16.13%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	2 / 153 (1.31%)	9 / 78 (11.54%)	1 / 18 (5.56%)
occurrences all number	5	3	5	1	0	0	1	1	0	1	3	10	1
Abdominal tenderness
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	1	0	0
Abdominal rigidity
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0
Abdominal pain upper
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	3 / 31 (9.68%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	7 / 153 (4.58%)	4 / 78 (5.13%)	2 / 18 (11.11%)
occurrences all number	1	1	3	0	1	0	0	1	0	1	9	4	2
Abdominal pain
subjects affected / exposed	9 / 46 (19.57%)	7 / 39 (17.95%)	1 / 31 (3.23%)	0 / 16 (0.00%)	2 / 10 (20.00%)	2 / 20 (10.00%)	1 / 21 (4.76%)	2 / 20 (10.00%)	2 / 5 (40.00%)	2 / 11 (18.18%)	15 / 153 (9.80%)	10 / 78 (12.82%)	0 / 18 (0.00%)
occurrences all number	11	9	1	0	3	3	1	2	2	3	17	12	0
Anal fissure
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	1	1	0	0	0	1	0	1	0	0	1	1	0
Anal incontinence
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	0	0	0	1	1	0	0	0	1	0
Anal ulcer
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Angina bullosa haemorrhagica
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	2 / 31 (6.45%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	3 / 78 (3.85%)	0 / 18 (0.00%)
occurrences all number	1	1	3	2	0	0	1	0	1	0	2	4	0
Colitis
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	2 / 10 (20.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	1 / 153 (0.65%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	2	2	0	0	2	0	0	0	0	1	1	2	0
Constipation
subjects affected / exposed	27 / 46 (58.70%)	24 / 39 (61.54%)	7 / 31 (22.58%)	4 / 16 (25.00%)	2 / 10 (20.00%)	5 / 20 (25.00%)	7 / 21 (33.33%)	10 / 20 (50.00%)	0 / 5 (0.00%)	7 / 11 (63.64%)	41 / 153 (26.80%)	34 / 78 (43.59%)	4 / 18 (22.22%)
occurrences all number	41	35	7	4	2	9	9	11	0	21	51	48	4
Diarrhoea
subjects affected / exposed	21 / 46 (45.65%)	16 / 39 (41.03%)	7 / 31 (22.58%)	5 / 16 (31.25%)	2 / 10 (20.00%)	5 / 20 (25.00%)	7 / 21 (33.33%)	5 / 20 (25.00%)	1 / 5 (20.00%)	4 / 11 (36.36%)	31 / 153 (20.26%)	29 / 78 (37.18%)	1 / 18 (5.56%)
occurrences all number	29	21	8	6	3	11	8	5	1	8	36	38	2
Dry mouth
subjects affected / exposed	4 / 46 (8.70%)	2 / 39 (5.13%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	4 / 153 (2.61%)	5 / 78 (6.41%)	1 / 18 (5.56%)
occurrences all number	4	2	1	0	0	1	0	0	0	0	4	5	1
Dyspepsia
subjects affected / exposed	4 / 46 (8.70%)	4 / 39 (10.26%)	2 / 31 (6.45%)	1 / 16 (6.25%)	1 / 10 (10.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	11 / 153 (7.19%)	6 / 78 (7.69%)	0 / 18 (0.00%)
occurrences all number	5	5	2	1	1	1	0	0	0	1	11	7	0
Dysphagia
subjects affected / exposed	3 / 46 (6.52%)	2 / 39 (5.13%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	3 / 153 (1.96%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	3	2	1	1	0	1	1	1	1	0	3	4	0
Eosinophilic colitis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1
Faeces discoloured
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	2 / 31 (6.45%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	0	0	3	1	0	0	0	0	0	0	0	3	0
Flatulence
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	2 / 153 (1.31%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	1	1	1	1	0	0	1	0	0	1	2	2	0
Frequent bowel movements
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0
Food poisoning
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1
Gastrointestinal haemorrhage
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	0	1	0	0	0	1	0
Gastritis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	1
Gingival bleeding
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	2 / 31 (6.45%)	2 / 16 (12.50%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	4 / 153 (2.61%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	3	3	3	3	0	1	1	0	0	1	9	6	0
Gastrooesophageal reflux disease
subjects affected / exposed	4 / 46 (8.70%)	4 / 39 (10.26%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	6 / 153 (3.92%)	5 / 78 (6.41%)	2 / 18 (11.11%)
occurrences all number	4	4	1	1	0	1	0	1	0	1	6	5	2
Haematemesis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Gingival swelling
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	0	1	0	0	0	0	0	0	1	0
Gingival pain
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	2 / 31 (6.45%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	2	2	2	1	0	0	0	0	0	1	0	4	0
Gingival hypertrophy
subjects affected / exposed	3 / 46 (6.52%)	3 / 39 (7.69%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	3 / 21 (14.29%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	5 / 153 (3.27%)	3 / 78 (3.85%)	0 / 18 (0.00%)
occurrences all number	3	3	0	0	0	0	4	0	0	0	6	3	0
Haemorrhoidal haemorrhage
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Haemorrhoids
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	3 / 20 (15.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	5 / 153 (3.27%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	2	2	0	0	0	1	0	3	0	1	5	2	0
Mouth haemorrhage
subjects affected / exposed	3 / 46 (6.52%)	3 / 39 (7.69%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	4 / 153 (2.61%)	3 / 78 (3.85%)	0 / 18 (0.00%)
occurrences all number	3	3	0	0	1	0	1	0	0	0	5	3	0
Mouth ulceration
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	5 / 153 (3.27%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	1	0	0	0	0	5	1	0
Nausea
subjects affected / exposed	32 / 46 (69.57%)	26 / 39 (66.67%)	14 / 31 (45.16%)	6 / 16 (37.50%)	2 / 10 (20.00%)	11 / 20 (55.00%)	9 / 21 (42.86%)	8 / 20 (40.00%)	3 / 5 (60.00%)	8 / 11 (72.73%)	59 / 153 (38.56%)	47 / 78 (60.26%)	5 / 18 (27.78%)
occurrences all number	43	37	23	11	6	14	14	11	4	12	78	68	7
Odynophagia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	2 / 20 (10.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	3 / 153 (1.96%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	0	3	0	0
Oral pain
subjects affected / exposed	3 / 46 (6.52%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	2 / 20 (10.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	3 / 78 (3.85%)	0 / 18 (0.00%)
occurrences all number	3	2	0	0	0	2	0	0	0	0	1	3	0
Oral disorder
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	3 / 153 (1.96%)	3 / 78 (3.85%)	0 / 18 (0.00%)
occurrences all number	2	2	1	1	0	0	0	0	0	0	3	3	0
Pancreatitis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Proctalgia
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	3 / 153 (1.96%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	2	2	2	0	0	0	0	1	0	0	3	4	0
Proctitis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1
Rectal haemorrhage
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	2 / 18 (11.11%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	1	2
Stomatitis haemorrhagic
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0
Stomatitis
subjects affected / exposed	5 / 46 (10.87%)	3 / 39 (7.69%)	2 / 31 (6.45%)	1 / 16 (6.25%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	2 / 20 (10.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	12 / 153 (7.84%)	7 / 78 (8.97%)	1 / 18 (5.56%)
occurrences all number	5	3	2	1	1	0	0	2	0	1	16	7	1
Toothache
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	2 / 31 (6.45%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	7 / 153 (4.58%)	2 / 78 (2.56%)	1 / 18 (5.56%)
occurrences all number	0	0	2	0	1	0	0	0	0	0	7	2	1
Tongue dysplasia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0
Varices oesophageal
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0
Vomiting
subjects affected / exposed	17 / 46 (36.96%)	14 / 39 (35.90%)	8 / 31 (25.81%)	3 / 16 (18.75%)	2 / 10 (20.00%)	10 / 20 (50.00%)	6 / 21 (28.57%)	6 / 20 (30.00%)	0 / 5 (0.00%)	4 / 11 (36.36%)	27 / 153 (17.65%)	25 / 78 (32.05%)	2 / 18 (11.11%)
occurrences all number	23	20	12	3	3	15	6	7	0	11	35	35	4
Hepatobiliary disorders
Cholelithiasis
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	1	1	0	0	0	1	0	0	0	0	0	2	0
Cholestasis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	2	0	1
Hepatic steatosis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	0	1	0	0	1	1	0
Jaundice
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0
Skin and subcutaneous tissue disorders
Actinic keratosis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	2	0	1
Alopecia
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	2 / 31 (6.45%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	5 / 153 (3.27%)	3 / 78 (3.85%)	0 / 18 (0.00%)
occurrences all number	1	1	2	1	0	0	0	0	0	0	6	3	0
Angioedema
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	0	0	0	0
Blister
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0
Blood blister
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	2	1	0
Dermatitis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0
Dermatitis acneiform
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Dry skin
subjects affected / exposed	3 / 46 (6.52%)	3 / 39 (7.69%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	4 / 78 (5.13%)	1 / 18 (5.56%)
occurrences all number	3	3	1	0	0	0	0	1	0	0	1	4	1
Ecchymosis
subjects affected / exposed	3 / 46 (6.52%)	3 / 39 (7.69%)	3 / 31 (9.68%)	2 / 16 (12.50%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	6 / 78 (7.69%)	0 / 18 (0.00%)
occurrences all number	4	4	3	2	0	0	0	0	1	0	1	7	0
Erythema
subjects affected / exposed	3 / 46 (6.52%)	3 / 39 (7.69%)	2 / 31 (6.45%)	1 / 16 (6.25%)	1 / 10 (10.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	1 / 153 (0.65%)	5 / 78 (6.41%)	1 / 18 (5.56%)
occurrences all number	5	5	2	1	1	0	1	0	0	1	1	7	1
Hidradenitis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Hyperhidrosis
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	3 / 31 (9.68%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	1 / 153 (0.65%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	1	1	3	1	0	0	0	0	0	1	1	4	0
Hyperkeratosis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0
Miliaria
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0
Night sweats
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	1 / 78 (1.28%)	1 / 18 (5.56%)
occurrences all number	1	1	0	0	0	0	1	0	0	1	0	1	1
Onychoclasis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	0	0	1	0	0	0	0	0	1	0
Onycholysis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0
Papule
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0
Petechiae
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	2 / 31 (6.45%)	1 / 16 (6.25%)	0 / 10 (0.00%)	2 / 20 (10.00%)	2 / 21 (9.52%)	0 / 20 (0.00%)	0 / 5 (0.00%)	2 / 11 (18.18%)	7 / 153 (4.58%)	3 / 78 (3.85%)	0 / 18 (0.00%)
occurrences all number	1	1	3	1	0	2	2	0	0	2	8	4	0
Pruritus generalised
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	1	0	1
Pruritus
subjects affected / exposed	8 / 46 (17.39%)	7 / 39 (17.95%)	4 / 31 (12.90%)	3 / 16 (18.75%)	1 / 10 (10.00%)	1 / 20 (5.00%)	2 / 21 (9.52%)	0 / 20 (0.00%)	0 / 5 (0.00%)	2 / 11 (18.18%)	8 / 153 (5.23%)	12 / 78 (15.38%)	2 / 18 (11.11%)
occurrences all number	9	8	4	3	2	1	3	0	0	3	10	13	3
Psoriasis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	1
Purpura
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	1	1	0	0	0	1	0	0	0	0	2	1	0
Pyoderma gangrenosum
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	2
Rash maculo-papular
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	2 / 20 (10.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	8 / 153 (5.23%)	1 / 78 (1.28%)	2 / 18 (11.11%)
occurrences all number	1	1	0	0	0	2	0	2	0	0	11	1	2
Rash erythematous
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	2	2	0	0	0	0	0	0	2	0	1	2	0
Rash
subjects affected / exposed	4 / 46 (8.70%)	4 / 39 (10.26%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	2 / 20 (10.00%)	2 / 21 (9.52%)	3 / 20 (15.00%)	0 / 5 (0.00%)	2 / 11 (18.18%)	12 / 153 (7.84%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	4	4	0	0	0	2	2	4	0	6	12	4	0
Rash papular
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	2	0	0	0
Scab
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	2
Skin hyperpigmentation
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	3 / 78 (3.85%)	0 / 18 (0.00%)
occurrences all number	2	2	1	0	0	1	0	0	0	0	0	3	0
Skin lesion
subjects affected / exposed	2 / 46 (4.35%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	7 / 153 (4.58%)	2 / 78 (2.56%)	1 / 18 (5.56%)
occurrences all number	3	2	0	0	0	1	0	0	0	0	7	3	2
Skin ulcer
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	3	3	0	0	0	0	0	1	0	0	1	3	0
Skin reaction
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	3	0	0	0	0	0	0	0
Skin mass
subjects affected / exposed	4 / 46 (8.70%)	4 / 39 (10.26%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	3 / 153 (1.96%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	4	4	0	0	0	0	0	0	0	1	6	4	0
Toxic skin eruption
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0
Urticaria
subjects affected / exposed	4 / 46 (8.70%)	4 / 39 (10.26%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	5 / 78 (6.41%)	0 / 18 (0.00%)
occurrences all number	5	5	1	1	0	0	1	0	0	0	2	6	0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	3 / 46 (6.52%)	2 / 39 (5.13%)	3 / 31 (9.68%)	2 / 16 (12.50%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	7 / 153 (4.58%)	6 / 78 (7.69%)	0 / 18 (0.00%)
occurrences all number	3	2	3	2	0	0	1	0	0	1	15	6	0
Calculus urinary
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	1	0
Dysuria
subjects affected / exposed	3 / 46 (6.52%)	3 / 39 (7.69%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	1 / 153 (0.65%)	4 / 78 (5.13%)	1 / 18 (5.56%)
occurrences all number	5	5	1	0	0	0	0	1	0	1	2	6	1
Haematuria
subjects affected / exposed	5 / 46 (10.87%)	5 / 39 (12.82%)	4 / 31 (12.90%)	3 / 16 (18.75%)	2 / 10 (20.00%)	3 / 20 (15.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	5 / 153 (3.27%)	9 / 78 (11.54%)	0 / 18 (0.00%)
occurrences all number	5	5	4	3	2	3	1	0	0	2	5	9	0
Hydronephrosis
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	1	1	1	1	0	0	0	0	0	0	0	2	0
Pollakiuria
subjects affected / exposed	5 / 46 (10.87%)	5 / 39 (12.82%)	2 / 31 (6.45%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	2 / 153 (1.31%)	7 / 78 (8.97%)	1 / 18 (5.56%)
occurrences all number	9	9	3	2	0	0	0	0	0	1	2	12	1
Renal failure
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	3 / 78 (3.85%)	0 / 18 (0.00%)
occurrences all number	2	2	1	1	0	0	1	1	0	0	2	3	0
Renal colic
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	1 / 153 (0.65%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	1	0	0
Urinary hesitation
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0
Urinary incontinence
subjects affected / exposed	3 / 46 (6.52%)	3 / 39 (7.69%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	2 / 11 (18.18%)	2 / 153 (1.31%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	3	3	1	0	0	1	0	1	0	2	2	4	0
Urinary retention
subjects affected / exposed	3 / 46 (6.52%)	3 / 39 (7.69%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	3 / 153 (1.96%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	4	4	1	0	0	0	0	0	0	0	3	5	0
Urinary tract pain
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	1	0
Endocrine disorders
Hypothyroidism
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	2	2	0	0	0	0	0	0	0	0	2	2	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	8 / 46 (17.39%)	8 / 39 (20.51%)	5 / 31 (16.13%)	2 / 16 (12.50%)	0 / 10 (0.00%)	0 / 20 (0.00%)	2 / 21 (9.52%)	1 / 20 (5.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	10 / 153 (6.54%)	13 / 78 (16.67%)	2 / 18 (11.11%)
occurrences all number	14	14	9	2	0	0	2	1	0	1	14	23	2
Articular calcification
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0
Back pain
subjects affected / exposed	5 / 46 (10.87%)	5 / 39 (12.82%)	4 / 31 (12.90%)	3 / 16 (18.75%)	0 / 10 (0.00%)	0 / 20 (0.00%)	2 / 21 (9.52%)	2 / 20 (10.00%)	0 / 5 (0.00%)	2 / 11 (18.18%)	21 / 153 (13.73%)	9 / 78 (11.54%)	4 / 18 (22.22%)
occurrences all number	10	10	5	4	0	0	3	2	0	4	29	15	4
Bone pain
subjects affected / exposed	2 / 46 (4.35%)	1 / 39 (2.56%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	2 / 11 (18.18%)	4 / 153 (2.61%)	3 / 78 (3.85%)	0 / 18 (0.00%)
occurrences all number	2	1	1	0	0	0	0	0	0	2	4	3	0
Bone swelling
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	2	0	0
Flank pain
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	2 / 31 (6.45%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	2	2	3	2	0	0	1	0	0	0	1	5	0
Joint swelling
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	3 / 78 (3.85%)	0 / 18 (0.00%)
occurrences all number	1	1	2	0	0	1	0	0	0	0	1	4	0
Joint effusion
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	2	0	0
Musculoskeletal pain
subjects affected / exposed	4 / 46 (8.70%)	4 / 39 (10.26%)	3 / 31 (9.68%)	2 / 16 (12.50%)	1 / 10 (10.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	6 / 153 (3.92%)	7 / 78 (8.97%)	0 / 18 (0.00%)
occurrences all number	4	4	5	3	1	1	0	0	0	0	7	9	0
Musculoskeletal chest pain
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	5 / 153 (3.27%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	1	1	1	0	0	1	0	2	1	0	5	2	0
Muscular weakness
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	2 / 31 (6.45%)	1 / 16 (6.25%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	6 / 153 (3.92%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	2	2	2	1	0	2	0	0	0	1	6	4	0
Muscle twitching
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0
Muscle tightness
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	1	0
Muscle spasms
subjects affected / exposed	1 / 46 (2.17%)	0 / 39 (0.00%)	2 / 31 (6.45%)	2 / 16 (12.50%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	3 / 153 (1.96%)	3 / 78 (3.85%)	1 / 18 (5.56%)
occurrences all number	1	0	3	3	0	0	1	0	1	0	3	4	1
Myalgia
subjects affected / exposed	3 / 46 (6.52%)	2 / 39 (5.13%)	3 / 31 (9.68%)	1 / 16 (6.25%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	6 / 78 (7.69%)	1 / 18 (5.56%)
occurrences all number	3	2	3	1	0	1	1	1	0	0	0	6	1
Neck pain
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	3 / 78 (3.85%)	0 / 18 (0.00%)
occurrences all number	2	2	1	1	0	1	0	0	0	0	3	3	0
Pain in extremity
subjects affected / exposed	8 / 46 (17.39%)	8 / 39 (20.51%)	4 / 31 (12.90%)	2 / 16 (12.50%)	0 / 10 (0.00%)	0 / 20 (0.00%)	2 / 21 (9.52%)	0 / 20 (0.00%)	0 / 5 (0.00%)	3 / 11 (27.27%)	13 / 153 (8.50%)	12 / 78 (15.38%)	0 / 18 (0.00%)
occurrences all number	13	13	4	2	0	0	2	0	0	4	18	17	0
Osteoporosis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	1	0	0	0	0	1	0
Osteoarthritis
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	3 / 153 (1.96%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	2	2	0	0	0	0	0	0	0	1	3	2	0
Pain in jaw
subjects affected / exposed	3 / 46 (6.52%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	3 / 78 (3.85%)	1 / 18 (5.56%)
occurrences all number	3	2	0	0	0	0	0	1	0	0	0	3	1
Periarthritis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	1	0	0
Rheumatoid arthritis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1
Seronegative arthritis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1
Infections and infestations
Aspergillus infection
subjects affected / exposed	1 / 46 (2.17%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	3 / 153 (1.96%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	1	0	3	1	0
Bacteraemia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	1 / 153 (0.65%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	1	0	0
Bronchopulmonary aspergillosis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	1 / 153 (0.65%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	1	0	0
Bronchitis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	6 / 153 (3.92%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	1	0	0	1	6	0	1
Candida infection
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	2 / 21 (9.52%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	1	1	0	0	0	0	3	0	0	0	3	1	0
Cellulitis
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	5 / 153 (3.27%)	1 / 78 (1.28%)	1 / 18 (5.56%)
occurrences all number	2	2	0	0	0	1	1	1	0	0	6	2	1
Chronic sinusitis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	1	0	0
Clostridium difficile colitis
subjects affected / exposed	1 / 46 (2.17%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	1	0	0	2	0
Conjunctivitis
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	3 / 153 (1.96%)	1 / 78 (1.28%)	1 / 18 (5.56%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	3	1	1
Corona virus infection
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	1 / 78 (1.28%)	1 / 18 (5.56%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	2	1	1
Cystitis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	4 / 153 (2.61%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	4	0	1
Device related infection
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	1 / 78 (1.28%)	1 / 18 (5.56%)
occurrences all number	1	1	0	0	1	0	0	0	0	0	1	1	1
Enterococcal bacteraemia
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	1	1	0	0	0	2	0	0	1	0	0	1	0
Enterobacter bacteraemia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0
Escherichia urinary tract infection
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	1	0	1
Escherichia bacteraemia
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	2	2	0	0	0	0	0	0	0	0	1	2	0
Erysipelas
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0
Fungal rhinitis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0
Gastroenteritis
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	3 / 153 (1.96%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	2	2	0	0	0	0	0	0	0	0	5	2	0
Genital infection fungal
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	1
Herpes zoster
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	4 / 153 (2.61%)	0 / 78 (0.00%)	2 / 18 (11.11%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	4	0	3
Herpes virus infection
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0
Klebsiella infection
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0
Lower respiratory tract infection
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	3 / 153 (1.96%)	1 / 78 (1.28%)	1 / 18 (5.56%)
occurrences all number	1	1	0	0	1	0	0	0	0	1	3	1	1
Lower respiratory tract infection fungal
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Lung infection
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0
Nail infection
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	1 / 153 (0.65%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	1	0	0
Nasopharyngitis
subjects affected / exposed	3 / 46 (6.52%)	3 / 39 (7.69%)	2 / 31 (6.45%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	2 / 153 (1.31%)	5 / 78 (6.41%)	1 / 18 (5.56%)
occurrences all number	4	4	2	1	0	0	0	0	0	1	2	6	1
Ophthalmic herpes zoster
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0
Oral herpes
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	3 / 153 (1.96%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	1	3	0	0
Oral fungal infection
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	3 / 153 (1.96%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	1	3	0	0
Oral candidiasis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	2 / 20 (10.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	3 / 153 (1.96%)	1 / 78 (1.28%)	1 / 18 (5.56%)
occurrences all number	0	0	1	1	0	3	0	0	1	0	3	1	1
Orchitis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0
Parainfluenzae virus infection
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0
Paronychia
subjects affected / exposed	1 / 46 (2.17%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	1 / 153 (0.65%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	1	1	1	0
Peritonsillar abscess
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Pharyngitis
subjects affected / exposed	2 / 46 (4.35%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	2	2	0	0	0	0	0	0	0	0	2	2	0
Pneumonia pseudomonal
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0
Pneumonia
subjects affected / exposed	5 / 46 (10.87%)	4 / 39 (10.26%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	8 / 153 (5.23%)	6 / 78 (7.69%)	0 / 18 (0.00%)
occurrences all number	5	4	1	1	0	1	1	0	2	0	8	6	0
Pseudomonal sepsis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	0	1	0	0
Rash pustular
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	2	0	1
Respiratory syncytial virus infection
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0
Respiratory tract infection
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	2	0	0	0	1	0	0
Rhinitis
subjects affected / exposed	4 / 46 (8.70%)	4 / 39 (10.26%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	3 / 153 (1.96%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	5	5	0	0	0	0	0	0	0	1	3	5	0
Sinusitis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	1 / 78 (1.28%)	1 / 18 (5.56%)
occurrences all number	0	0	1	0	0	2	1	0	0	0	2	1	1
Staphylococcal sepsis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Staphylococcal infection
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	3 / 153 (1.96%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	1	1	0	0	1	0	0	0	0	0	3	1	0
Staphylococcal bacteraemia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0
Tooth infection
subjects affected / exposed	1 / 46 (2.17%)	1 / 39 (2.56%)	1 / 31 (3.23%)	1 / 16 (6.25%)	1 / 10 (10.00%)	2 / 20 (10.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	1 / 153 (0.65%)	2 / 78 (2.56%)	2 / 18 (11.11%)
occurrences all number	1	1	1	1	1	3	0	0	0	2	1	2	2
Tooth abscess
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	2 / 10 (20.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	3 / 153 (1.96%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	0	3	0	0
Upper respiratory tract infection
subjects affected / exposed	5 / 46 (10.87%)	4 / 39 (10.26%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	2 / 20 (10.00%)	2 / 21 (9.52%)	0 / 20 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	10 / 153 (6.54%)	5 / 78 (6.41%)	2 / 18 (11.11%)
occurrences all number	5	4	0	0	1	2	4	0	0	1	10	5	4
Urinary tract infection
subjects affected / exposed	3 / 46 (6.52%)	3 / 39 (7.69%)	1 / 31 (3.23%)	0 / 16 (0.00%)	2 / 10 (20.00%)	1 / 20 (5.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	14 / 153 (9.15%)	4 / 78 (5.13%)	2 / 18 (11.11%)
occurrences all number	4	4	1	0	3	1	1	0	0	0	20	5	2
Vulvovaginal mycotic infection
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	0 / 78 (0.00%)	1 / 18 (5.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	2	0	1
Metabolism and nutrition disorders
Abnormal loss of weight
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0
Decreased appetite
subjects affected / exposed	10 / 46 (21.74%)	8 / 39 (20.51%)	7 / 31 (22.58%)	3 / 16 (18.75%)	3 / 10 (30.00%)	4 / 20 (20.00%)	4 / 21 (19.05%)	5 / 20 (25.00%)	0 / 5 (0.00%)	3 / 11 (27.27%)	26 / 153 (16.99%)	17 / 78 (21.79%)	1 / 18 (5.56%)
occurrences all number	14	12	7	3	5	5	5	7	0	3	39	21	1
Dehydration
subjects affected / exposed	4 / 46 (8.70%)	3 / 39 (7.69%)	2 / 31 (6.45%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	3 / 153 (1.96%)	6 / 78 (7.69%)	0 / 18 (0.00%)
occurrences all number	7	6	2	1	0	0	0	0	0	0	4	9	0
Diabetes mellitus
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	1	0	0
Fluid overload
subjects affected / exposed	4 / 46 (8.70%)	2 / 39 (5.13%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	5 / 78 (6.41%)	0 / 18 (0.00%)
occurrences all number	4	2	1	0	0	0	0	0	0	0	2	5	0
Hyperkalaemia
subjects affected / exposed	2 / 46 (4.35%)	1 / 39 (2.56%)	1 / 31 (3.23%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	3 / 153 (1.96%)	3 / 78 (3.85%)	0 / 18 (0.00%)
occurrences all number	2	1	1	0	0	0	0	1	0	0	3	3	0
Hypercalcaemia
subjects affected / exposed	1 / 46 (2.17%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	1 / 18 (5.56%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	1	1
Hyperferritinaemia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0
Hyperglycaemia
subjects affected / exposed	3 / 46 (6.52%)	3 / 39 (7.69%)	3 / 31 (9.68%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	1 / 20 (5.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	7 / 153 (4.58%)	6 / 78 (7.69%)	0 / 18 (0.00%)
occurrences all number	3	3	3	1	0	0	1	1	0	0	7	6	0
Hypernatraemia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	1	0
Hyperphosphataemia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	2 / 31 (6.45%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	2 / 78 (2.56%)	0 / 18 (0.00%)
occurrences all number	0	0	2	0	0	0	1	0	2	0	2	2	0
Hyperuricaemia
subjects affected / exposed	4 / 46 (8.70%)	3 / 39 (7.69%)	4 / 31 (12.90%)	2 / 16 (12.50%)	0 / 10 (0.00%)	2 / 20 (10.00%)	1 / 21 (4.76%)	2 / 20 (10.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	6 / 153 (3.92%)	8 / 78 (10.26%)	0 / 18 (0.00%)
occurrences all number	4	3	4	2	0	2	1	4	0	1	9	8	0
Hypervolaemia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0
Hypoalbuminaemia
subjects affected / exposed	5 / 46 (10.87%)	3 / 39 (7.69%)	2 / 31 (6.45%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	7 / 78 (8.97%)	0 / 18 (0.00%)
occurrences all number	5	3	2	1	0	0	0	0	1	0	2	7	0
Hypocalcaemia
subjects affected / exposed	5 / 46 (10.87%)	3 / 39 (7.69%)	3 / 31 (9.68%)	1 / 16 (6.25%)	1 / 10 (10.00%)	0 / 20 (0.00%)	2 / 21 (9.52%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	8 / 78 (10.26%)	0 / 18 (0.00%)
occurrences all number	8	6	3	1	1	0	2	0	2	0	2	11	0
Hypokalaemia
subjects affected / exposed	16 / 46 (34.78%)	13 / 39 (33.33%)	7 / 31 (22.58%)	2 / 16 (12.50%)	1 / 10 (10.00%)	6 / 20 (30.00%)	1 / 21 (4.76%)	4 / 20 (20.00%)	3 / 5 (60.00%)	4 / 11 (36.36%)	33 / 153 (21.57%)	23 / 78 (29.49%)	1 / 18 (5.56%)
occurrences all number	21	18	8	2	1	11	1	4	8	4	56	29	1
Hypomagnesaemia
subjects affected / exposed	5 / 46 (10.87%)	5 / 39 (12.82%)	3 / 31 (9.68%)	2 / 16 (12.50%)	1 / 10 (10.00%)	1 / 20 (5.00%)	1 / 21 (4.76%)	3 / 20 (15.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	8 / 153 (5.23%)	8 / 78 (10.26%)	0 / 18 (0.00%)
occurrences all number	5	5	3	2	1	2	1	3	2	0	9	8	0
Hyponatraemia
subjects affected / exposed	5 / 46 (10.87%)	5 / 39 (12.82%)	3 / 31 (9.68%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	6 / 153 (3.92%)	8 / 78 (10.26%)	0 / 18 (0.00%)
occurrences all number	5	5	3	1	0	0	0	0	0	0	10	8	0
Hypophosphataemia
subjects affected / exposed	4 / 46 (8.70%)	2 / 39 (5.13%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 21 (4.76%)	3 / 20 (15.00%)	2 / 5 (40.00%)	1 / 11 (9.09%)	6 / 153 (3.92%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	4	2	0	0	0	1	1	4	3	1	7	4	0
Hypovolaemia
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	1	0	0	0	0	1	0
Increased appetite
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	1 / 31 (3.23%)	1 / 16 (6.25%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	1 / 78 (1.28%)	0 / 18 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	1	0
Iron deficiency
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0
Lactic acidosis
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0
Malnutrition
subjects affected / exposed	4 / 46 (8.70%)	4 / 39 (10.26%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 153 (0.00%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	4	4	0	0	0	0	0	0	0	0	0	4	0
Type 2 diabetes mellitus
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	0 / 10 (0.00%)	1 / 20 (5.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 153 (0.65%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	1	0	0
Tumour lysis syndrome
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	4 / 31 (12.90%)	1 / 16 (6.25%)	0 / 10 (0.00%)	1 / 20 (5.00%)	1 / 21 (4.76%)	0 / 20 (0.00%)	1 / 5 (20.00%)	1 / 11 (9.09%)	3 / 153 (1.96%)	4 / 78 (5.13%)	0 / 18 (0.00%)
occurrences all number	0	0	5	1	0	1	2	0	1	1	3	5	0
Vitamin D deficiency
subjects affected / exposed	0 / 46 (0.00%)	0 / 39 (0.00%)	0 / 31 (0.00%)	0 / 16 (0.00%)	1 / 10 (10.00%)	0 / 20 (0.00%)	0 / 21 (0.00%)	0 / 20 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 153 (1.31%)	0 / 78 (0.00%)	0 / 18 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	2	0	0

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Were there any global substantial amendments to the protocol? Yes

20 Aug 2020

Protocol Amendment 6: Focused on safety follow-up with scheduled assessments performed every 2 cycles, to begin with Cycle 5 for ongoing subjects. Removal of continued assessment of PK, PD, mutational analyses, and QOL parameters. Reduction of frequency of efficacy response assessments to every 6 cycles except in case of suspicion of relapse/progression (subjects with AML) or as clinically indicated (subjects with MDS).

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

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Clinical trials

Clinical Trial Results: A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination With Azacitidine or Cytarabine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Phase 1: Number of Subjects With Treatment emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Primary: Phase 1: Number of Subjects With Treatment emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Primary: Phase 1: Number of Subjects With Change From Baseline in Clinically Significant Abnormal Laboratory Values

Primary: Phase 1: Number of Subjects With Change From Baseline in Clinically Significant Abnormal Laboratory Values

Primary: Phase 1: Number of Subjects With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)

Primary: Phase 1: Number of Subjects With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)

Primary: Phase 2, Cohort 3, 4, 5, 6, 7, 8: Percentage of Subjects with CR Plus CRh for Acute Myeloid Leukemia Assessed by Investigator Based on IWG Response Criteria

Primary: Phase 2, Cohort 3, 4, 5, 6, 7, 8: Percentage of Subjects with CR Plus CRh for Acute Myeloid Leukemia Assessed by Investigator Based on IWG Response Criteria

Primary: Phase 2, Cohort 1: Percentage of Subjects with Complete Remission (CR) Plus Complete Remission with Partial Hematological Recovery (CRh) for Acute Myeloid Leukemia Assessed by Investigator Based on International Working Group (IWG) Response Criteria

Primary: Phase 2, Cohort 1: Percentage of Subjects with Complete Remission (CR) Plus Complete Remission with Partial Hematological Recovery (CRh) for Acute Myeloid Leukemia Assessed by Investigator Based on International Working Group (IWG) Response Criteria

Primary: Phase 2: Percentage of Subjects with CR for MDS Assessed by IWG Response Criteria

Primary: Phase 2: Percentage of Subjects with CR for MDS Assessed by IWG Response Criteria

Primary: Phase 2: Four-month Relapse Free survival (RFS) Rate (Cohort 2)

Primary: Phase 2: Four-month Relapse Free survival (RFS) Rate (Cohort 2)

Secondary: Phase 1: Area Under the Curve (AUClast) for FT-2102

Secondary: Phase 1: Area Under the Curve (AUClast) for FT-2102

Secondary: Phase 1: Maximum Plasma Concentration (Cmax) for FT-2102

Secondary: Phase 1: Maximum Plasma Concentration (Cmax) for FT-2102

Secondary: Phase 1: Time to Maximum Plasma Concentration (Tmax) for FT-2102

Secondary: Phase 1: Time to Maximum Plasma Concentration (Tmax) for FT-2102

Secondary: Phase 1: Time to Response (TTR) for AML

Secondary: Phase 1: Time to Response (TTR) for AML

Secondary: Phase 1: Duration of Overall Response for AML

Secondary: Phase 1: Duration of Overall Response for AML

Secondary: Phase 1: Time to Response (TTR) for MDS

Secondary: Phase 1: Time to Response (TTR) for MDS

Secondary: Phase 2: Time to Response (TTR) for Acute Myeloid Leukemia (AML)

Secondary: Phase 2: Time to Response (TTR) for Acute Myeloid Leukemia (AML)

Secondary: Phase 2: Duration of Overall Response for Acute Myeloid Leukemia (AML)

Secondary: Phase 2: Duration of Overall Response for Acute Myeloid Leukemia (AML)

Secondary: Phase 2: Time to Response (TTR) for Myelodysplastic Syndrome (MDS)

Secondary: Phase 2: Time to Response (TTR) for Myelodysplastic Syndrome (MDS)

Secondary: Phase 2: Duration of Overall Response for Myelodysplastic Syndrome (MDS)

Secondary: Phase 2: Duration of Overall Response for Myelodysplastic Syndrome (MDS)

Secondary: Phase 2 Cohort 2: Time to Relapse-Free Survival (RFS)

Secondary: Phase 2 Cohort 2: Time to Relapse-Free Survival (RFS)

Secondary: Phase 2: Overall Survival (OS)

Secondary: Phase 2: Overall Survival (OS)

Secondary: Phase 2: Event-free survival (EFS)

Secondary: Phase 2: Event-free survival (EFS)

Secondary: Phase 2: Transfusion Independence

Secondary: Phase 2: Transfusion Independence

Secondary: Phase 2: Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Secondary: Phase 2: Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Secondary: Phase 2: Number of Subjects With Change From Baseline in Clinically Significant Abnormal Laboratory Values

Secondary: Phase 2: Number of Subjects With Change From Baseline in Clinically Significant Abnormal Laboratory Values

Secondary: Phase 2: Number of Subjects With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)

Secondary: Phase 2: Number of Subjects With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG)

Secondary: Phase 2: Area Under the Curve (AUClast) for FT-2102

Secondary: Phase 2: Area Under the Curve (AUClast) for FT-2102

Secondary: Phase 2: Maximum Plasma Concentration (Cmax) for FT-2102

Secondary: Phase 2: Maximum Plasma Concentration (Cmax) for FT-2102

Secondary: Phase 2: Time to Maximum Plasma Concentration (Tmax) for FT-2102

Secondary: Phase 2: Time to Maximum Plasma Concentration (Tmax) for FT-2102

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination With Azacitidine or Cytarabine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation