Trial Outcomes & Findings for A Phase I / II Trial of Nintedanib in Asian Hepatocellular Carcinoma Patients (NCT NCT00987935)
NCT ID: NCT00987935
Last Updated: 2016-03-10
Results Overview
The MTD was defined as the highest dose studied for which the incidence of DLTs was 0/3 or less than 2/6 patients during the first treatment course.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
134 participants
Primary outcome timeframe
4 weeks
Results posted on
2016-03-10
Participant Flow
The trial consisted of 2 Phases. Patients were stratified into 1 of 2 groups according to their aspartate aminotransferase (AST)/alanine aminotransferase (ALT) and Child-Pugh score at baseline.
Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST (aspartate aminotransferase ) and ALT (alanine transaminase) ≤2 times the upper limit of normal (ULN). Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN
Participant milestones
| Measure |
Phase I Group I, 100 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 1, 150 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 1, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 50 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 100 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 150 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase II, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
Phase II, 400 mg Sorafenib Bid
Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
3
|
3
|
7
|
3
|
16
|
63
|
32
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
3
|
3
|
7
|
3
|
15
|
62
|
32
|
Reasons for withdrawal
| Measure |
Phase I Group I, 100 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 1, 150 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 1, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 50 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 100 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 150 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase II, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
Phase II, 400 mg Sorafenib Bid
Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Progressive disease
|
3
|
2
|
3
|
2
|
5
|
3
|
9
|
48
|
23
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
1
|
1
|
0
|
2
|
10
|
6
|
|
Overall Study
Refused to continue taking trial med.
|
1
|
0
|
0
|
0
|
1
|
0
|
4
|
4
|
2
|
|
Overall Study
Reason other than those specified above
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Phase I / II Trial of Nintedanib in Asian Hepatocellular Carcinoma Patients
Baseline characteristics by cohort
| Measure |
Phase I Group I, 100 mg Nintedanib Bid
n=4 Participants
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 1, 150 mg Nintedanib Bid
n=3 Participants
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 1, 200 mg Nintedanib Bid
n=3 Participants
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 50 mg Nintedanib Bid
n=3 Participants
Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 100 mg Nintedanib Bid
n=7 Participants
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 150 mg Nintedanib Bid
n=3 Participants
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 200 mg Nintedanib Bid
n=16 Participants
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase II, 200 mg Nintedanib Bid
n=63 Participants
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
Phase II, 400 mg Sorafenib Bid
n=32 Participants
Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
47.7 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
64.3 years
STANDARD_DEVIATION 15.3 • n=4 Participants
|
62.3 years
STANDARD_DEVIATION 11.1 • n=21 Participants
|
68.7 years
STANDARD_DEVIATION 10.1 • n=10 Participants
|
56.1 years
STANDARD_DEVIATION 11.7 • n=115 Participants
|
58.2 years
STANDARD_DEVIATION 12.6 • n=24 Participants
|
61.2 years
STANDARD_DEVIATION 11.5 • n=42 Participants
|
58.6 years
STANDARD_DEVIATION 12.3 • n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
57 Participants
n=24 Participants
|
26 Participants
n=42 Participants
|
118 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Treated set (Patients from the dose escalation part that were not replaced for MTD determination)
The MTD was defined as the highest dose studied for which the incidence of DLTs was 0/3 or less than 2/6 patients during the first treatment course.
Outcome measures
| Measure |
Group 1
n=9 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Group 2
n=15 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Phase I Group 1, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 50 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 100 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 150 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase II, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
Phase II, 400 mg Sorafenib Bid
Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose in Phase I
|
200 mg
|
200 mg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From randomization until data cut-off (28 Sep 2012); Up to 77 weeksPopulation: Treated set, only phase II participants.
TTP according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0 criteria based on central independent review. TTP RECIST 1.0 was defined as the time from randomisation to disease progression according to RECIST 1.0.
Outcome measures
| Measure |
Group 1
n=63 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Group 2
n=32 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Phase I Group 1, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 50 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 100 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 150 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase II, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
Phase II, 400 mg Sorafenib Bid
Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Progression (TTP) in Phase II
|
2.73 months
Interval 0.99 to 5.55
|
3.71 months
Interval 1.77 to 7.36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization until disease progression or data cut-off (16 Jul 2014); Up to 171 weeksPopulation: Treated set, Only phase II participants
TTP according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0 criteria based on central independent review. TTP RECIST 1.0 was defined as the time from randomisation to disease progression according to RECIST 1.0.
Outcome measures
| Measure |
Group 1
n=63 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Group 2
n=32 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Phase I Group 1, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 50 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 100 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 150 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase II, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
Phase II, 400 mg Sorafenib Bid
Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Progression (TTP) in Phase II (Follow-up Analyses)
|
2.76 months
Interval 0.99 to 5.55
|
3.71 months
Interval 1.77 to 7.36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)Population: Treated set
Incidence and worst intensity (severity) of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).
Outcome measures
| Measure |
Group 1
n=4 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Group 2
n=3 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Phase I Group 1, 200 mg Nintedanib Bid
n=3 Participants
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 50 mg Nintedanib Bid
n=3 Participants
Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 100 mg Nintedanib Bid
n=7 Participants
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 150 mg Nintedanib Bid
n=3 Participants
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 200 mg Nintedanib Bid
n=16 Participants
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase II, 200 mg Nintedanib Bid
n=63 Participants
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
Phase II, 400 mg Sorafenib Bid
n=32 Participants
Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
|---|---|---|---|---|---|---|---|---|---|
|
Incidence and Intensity of Adverse Events (AEs) Reported as the Number of Patients With AEs According to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Throughout the Treatment Period.
Grade 5
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
5 participants
|
10 participants
|
4 participants
|
|
Incidence and Intensity of Adverse Events (AEs) Reported as the Number of Patients With AEs According to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Throughout the Treatment Period.
Grade 1
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
12 participants
|
1 participants
|
|
Incidence and Intensity of Adverse Events (AEs) Reported as the Number of Patients With AEs According to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Throughout the Treatment Period.
Grade 2
|
2 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
4 participants
|
15 participants
|
4 participants
|
|
Incidence and Intensity of Adverse Events (AEs) Reported as the Number of Patients With AEs According to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Throughout the Treatment Period.
Grade 3
|
2 participants
|
1 participants
|
1 participants
|
1 participants
|
3 participants
|
2 participants
|
5 participants
|
17 participants
|
18 participants
|
|
Incidence and Intensity of Adverse Events (AEs) Reported as the Number of Patients With AEs According to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Throughout the Treatment Period.
Grade 4
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
1 participants
|
8 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Treated set (Phase I patients from the dose escalation part that were not replaced for MTD determination).
Number of patients with dose limiting toxicity are presented
Outcome measures
| Measure |
Group 1
n=3 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Group 2
n=3 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Phase I Group 1, 200 mg Nintedanib Bid
n=3 Participants
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 50 mg Nintedanib Bid
n=3 Participants
Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 100 mg Nintedanib Bid
n=6 Participants
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 150 mg Nintedanib Bid
n=3 Participants
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 200 mg Nintedanib Bid
n=3 Participants
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase II, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
Phase II, 400 mg Sorafenib Bid
Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Dose Limiting Toxicity in Phase I
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization until data cut-off (16 July 2014); Up to 171 weeksPopulation: Treated set, only phase II participants.
Objective RECIST 1.0 tumour response was defined as Complete Response (CR) or Partial Response (PR) and was derived from the patient's best objective RECIST 1.0 response based on central independent review. 95% Confidence Interval presented below are computed by Clopper and Pearson method.
Outcome measures
| Measure |
Group 1
n=63 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Group 2
n=32 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Phase I Group 1, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 50 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 100 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 150 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase II, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
Phase II, 400 mg Sorafenib Bid
Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
|---|---|---|---|---|---|---|---|---|---|
|
Objective Tumour Response by RECIST
|
6.3 percentage of participants
Interval 1.8 to 15.5
|
3.1 percentage of participants
Interval 0.1 to 16.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization until data cut-off (16 July 2014); Up to 171 weeksPopulation: Treated set, only phase II participants.
PFS by RECIST 1.0 was defined as the duration from date of randomisation to date of progression or death, whichever occurred earlier, based on central independent review.
Outcome measures
| Measure |
Group 1
n=63 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Group 2
n=32 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Phase I Group 1, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 50 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 100 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 150 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase II, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
Phase II, 400 mg Sorafenib Bid
Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
2.66 months
Interval 0.99 to 5.55
|
3.71 months
Interval 1.77 to 7.36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization until data cut-off (16 July 2014); Up to 171 weeksPopulation: Treated set, include only phase II participants
Overall survival was defined as the duration from date of randomisation to the date of death.
Outcome measures
| Measure |
Group 1
n=63 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Group 2
n=32 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Phase I Group 1, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 50 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 100 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 150 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase II, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
Phase II, 400 mg Sorafenib Bid
Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival
|
10.18 months
Interval 5.19 to 16.85
|
10.71 months
Interval 7.29 to 16.66
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day1, Day15 and Day 16Population: Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.
AUC0-12,ss,norm (area under the plasma concentration-time curve between 0 and 12 hours at steady state, normalised values) of Nintedanib Detailed time points of sampling are: Phase I and selected phase II patients in the Nintedanib arm: Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15.
Outcome measures
| Measure |
Group 1
n=20 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Group 2
n=20 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Phase I Group 1, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 50 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 100 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 150 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase II, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
Phase II, 400 mg Sorafenib Bid
Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
|---|---|---|---|---|---|---|---|---|---|
|
AUC0-12,ss,Norm (Area Under the Plasma Concentration-time Curve Between 0 and 12 Hours at Steady State, Normalised Values) of Nintedanib
|
1.97 (ng*h/mL)/mg
Geometric Coefficient of Variation 97.1
|
3.82 (ng*h/mL)/mg
Geometric Coefficient of Variation 64.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day1, Day15 and Day 16Population: Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.
AUC0-12,ss,norm (area under the plasma concentration-time curve between 0 and 12 hours at steady state, normalised values) of BIBF 1202 (metabolite of Nintedanib). Detailed time points of sampling are: Phase I and selected phase II patients in the Nintedanib arm: Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15.
Outcome measures
| Measure |
Group 1
n=20 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Group 2
n=20 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Phase I Group 1, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 50 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 100 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 150 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase II, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
Phase II, 400 mg Sorafenib Bid
Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
|---|---|---|---|---|---|---|---|---|---|
|
AUC0-12,ss,Norm (Area Under the Plasma Concentration-time Curve Between 0 and 12 Hours at Steady State, Normalised Values) of BIBF 1202 (Metabolite of Nintedanib)
|
3.50 (ng*h/mL)/mg
Geometric Coefficient of Variation 157
|
8.95 (ng*h/mL)/mg
Geometric Coefficient of Variation 114
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day1, Day15 and Day 16Population: Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.
AUC0-12,ss,norm of BIBF 1202 glucuronide (Metabolite of Nintedanib): Detailed time points of sampling are: Phase I and selected phase II patients in the Nintedanib arm: Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15.
Outcome measures
| Measure |
Group 1
n=20 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Group 2
n=20 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Phase I Group 1, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 50 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 100 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 150 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase II, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
Phase II, 400 mg Sorafenib Bid
Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
|---|---|---|---|---|---|---|---|---|---|
|
AUC0-12,ss,Norm (Area Under the Plasma Concentration-time Curve Between 0 and 12 Hours at Steady State, Normalised Values) of BIBF 1202 Glucuronide (Metabolite of Nintedanib)
|
16.9 (ng*h/mL)/mg
Geometric Coefficient of Variation 144
|
45.0 (ng*h/mL)/mg
Geometric Coefficient of Variation 124
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day1, Day15 and Day 16Population: Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.
Cmax,ss,norm (maximum concentration of the Nintedanib in plasma at steady state, normalised values). Detailed time points of sampling are: Phase I and selected phase II patients in the Nintedanib arm: Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15.
Outcome measures
| Measure |
Group 1
n=22 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Group 2
n=23 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Phase I Group 1, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 50 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 100 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 150 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase II, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
Phase II, 400 mg Sorafenib Bid
Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
|---|---|---|---|---|---|---|---|---|---|
|
Cmax,ss,Norm (Maximum Concentration of the Nintedanib in Plasma at Steady State, Normalised Values)
|
0.348 (ng/mL)/mg
Geometric Coefficient of Variation 98.8
|
0.630 (ng/mL)/mg
Geometric Coefficient of Variation 68.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day1, Day15 and Day 16Population: Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.
Cmax,ss,norm (maximum concentration of the BIBF 1202 in plasma at steady state, normalised values). Detailed time points of sampling are: Phase I and selected phase II patients in the Nintedanib arm: Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15.
Outcome measures
| Measure |
Group 1
n=22 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Group 2
n=23 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Phase I Group 1, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 50 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 100 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 150 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase II, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
Phase II, 400 mg Sorafenib Bid
Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
|---|---|---|---|---|---|---|---|---|---|
|
Cmax,ss,Norm (Maximum Concentration of the BIBF 1202 in Plasma at Steady State, Normalised Values)
|
0.519 (ng/mL)/mg
Geometric Coefficient of Variation 148
|
1.01 (ng/mL)/mg
Geometric Coefficient of Variation 118
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day1, Day15 and Day 16Population: Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.
Cmax,ss,norm (maximum concentration of the BIBF 1202 glucuronide in plasma at steady state, normalised values). Detailed time points of sampling are: Phase I and selected phase II patients in the Nintedanib arm: Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15.
Outcome measures
| Measure |
Group 1
n=22 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Group 2
n=23 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Phase I Group 1, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 50 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 100 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 150 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase II, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
Phase II, 400 mg Sorafenib Bid
Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
|---|---|---|---|---|---|---|---|---|---|
|
Cmax,ss,Norm (Maximum Concentration of the BIBF 1202 Glucuronide in Plasma at Steady State, Normalised Values)
|
1.56 (ng/mL)/mg
Geometric Coefficient of Variation 139
|
3.48 (ng/mL)/mg
Geometric Coefficient of Variation 139
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 to 4 hours (h), 4 to 12 h, and 12 to 24 h after nintedanibPopulation: Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.
fe0-12,ss (fraction excreted in urine between 0 and 12 hours at steady state) for Nintedanib. The reported value corresponds to the percentage of administered dose.
Outcome measures
| Measure |
Group 1
n=22 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Group 2
n=23 Participants
Patients treated with nintedanib belonging to Group1 from the 2 phases,
Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)
Phase II treatment consists of Nintedanib 200 mg twice daily (bid)
|
Phase I Group 1, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 50 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 100 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 150 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase I Group 2, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib.
|
Phase II, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
Phase II, 400 mg Sorafenib Bid
Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).
Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS).
|
|---|---|---|---|---|---|---|---|---|---|
|
fe0-12,ss (Fraction Excreted in Urine Between 0 and 12 Hours at Steady State) for Nintedanib
|
0.227 percentage
Geometric Coefficient of Variation 94.6
|
0.286 percentage
Geometric Coefficient of Variation 46.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase I Group I Nintedanib, 100 mg Bid
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase I Group I Nintedanib, 150 mg Bid
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I Group I Nintedanib, 200 mg Bid
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I Group II Nintedanib, 50 mg Bid
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I Group II Nintedanib, 100 mg Bid
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase I Group II Nintedanib, 150 mg Bid
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I Group II Nintedanib, 200 mg Bid
Serious events: 10 serious events
Other events: 16 other events
Deaths: 0 deaths
Phase II Nintedanib, 200 mg Bid
Serious events: 29 serious events
Other events: 61 other events
Deaths: 0 deaths
Phase II Sorafenib, 400 mg Bid
Serious events: 18 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I Group I Nintedanib, 100 mg Bid
n=4 participants at risk
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid) for the Group I patients during Phase I
|
Phase I Group I Nintedanib, 150 mg Bid
n=3 participants at risk
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid) for the Group I patients during Phase I
|
Phase I Group I Nintedanib, 200 mg Bid
n=3 participants at risk
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid) for the Group I patients during Phase I
|
Phase I Group II Nintedanib, 50 mg Bid
n=3 participants at risk
Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
|
Phase I Group II Nintedanib, 100 mg Bid
n=7 participants at risk
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
|
Phase I Group II Nintedanib, 150 mg Bid
n=3 participants at risk
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
|
Phase I Group II Nintedanib, 200 mg Bid
n=16 participants at risk
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
|
Phase II Nintedanib, 200 mg Bid
n=63 participants at risk
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid) during Phase II
|
Phase II Sorafenib, 400 mg Bid
n=32 participants at risk
Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid) during Phase II
|
|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
28.6%
2/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
9.5%
6/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal sinus cancer
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour rupture
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.2%
2/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.2%
2/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
4.8%
3/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
General disorders
Asthenia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
General disorders
Chest pain
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
General disorders
Disease progression
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
General disorders
Fatigue
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
General disorders
Malaise
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
General disorders
Pyrexia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.3%
4/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
9.4%
3/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
12.5%
2/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.2%
2/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Infections and infestations
Septic shock
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
12.5%
2/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Blood urea increased
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.2%
2/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Nervous system disorders
Sciatica
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.2%
2/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Vascular disorders
Visceral arterial ischaemia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
Other adverse events
| Measure |
Phase I Group I Nintedanib, 100 mg Bid
n=4 participants at risk
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid) for the Group I patients during Phase I
|
Phase I Group I Nintedanib, 150 mg Bid
n=3 participants at risk
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid) for the Group I patients during Phase I
|
Phase I Group I Nintedanib, 200 mg Bid
n=3 participants at risk
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid) for the Group I patients during Phase I
|
Phase I Group II Nintedanib, 50 mg Bid
n=3 participants at risk
Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
|
Phase I Group II Nintedanib, 100 mg Bid
n=7 participants at risk
Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
|
Phase I Group II Nintedanib, 150 mg Bid
n=3 participants at risk
Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
|
Phase I Group II Nintedanib, 200 mg Bid
n=16 participants at risk
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
|
Phase II Nintedanib, 200 mg Bid
n=63 participants at risk
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid) during Phase II
|
Phase II Sorafenib, 400 mg Bid
n=32 participants at risk
Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid) during Phase II
|
|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
100.0%
3/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
28.6%
2/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
50.0%
8/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
39.7%
25/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
25.0%
8/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
18.8%
3/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
19.0%
12/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
15.6%
5/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
12.5%
2/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.3%
4/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.3%
4/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
25.0%
4/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
17.5%
11/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
21.9%
7/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Eye disorders
Eye discharge
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Eye disorders
Orbital oedema
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
4.8%
3/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
42.9%
3/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
18.8%
3/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
28.6%
18/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
9.4%
3/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
12.5%
2/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
17.5%
11/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
31.2%
10/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
25.0%
4/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
22.2%
14/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
34.4%
11/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Abdominal tenderness
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
12.5%
2/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
19.0%
12/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
9.4%
3/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
20.6%
13/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
21.9%
7/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
71.4%
5/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
100.0%
3/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
37.5%
6/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
44.4%
28/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
56.2%
18/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
12.5%
2/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
7.9%
5/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.2%
2/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Gastritis
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.3%
4/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
25.0%
4/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
7.9%
5/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
4.8%
3/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
28.6%
2/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
43.8%
7/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
30.2%
19/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
12.5%
4/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Plicated tongue
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Portal hypertensive gastropathy
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
9.4%
3/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
31.2%
5/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
30.2%
19/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
15.6%
5/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
General disorders
Asthenia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
11.1%
7/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
9.4%
3/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
General disorders
Chest pain
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.2%
2/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
12.5%
4/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
General disorders
Chills
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
General disorders
Fatigue
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
42.9%
3/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
31.2%
5/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
22.2%
14/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
12.5%
4/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.2%
2/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
General disorders
Malaise
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.3%
4/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
12.5%
2/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.2%
2/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
General disorders
Oedema
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.3%
4/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
9.4%
3/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
25.0%
4/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
17.5%
11/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
12.5%
4/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
General disorders
Pyrexia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
25.0%
4/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
19.0%
12/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
18.8%
6/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
General disorders
Tenderness
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.3%
4/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
7.9%
5/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.2%
2/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
12.5%
2/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
7.9%
5/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
12.5%
2/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
11.1%
7/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
21.9%
7/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
28.6%
2/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
25.0%
4/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
9/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
31.2%
10/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
28.6%
2/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
12.5%
2/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
9.5%
6/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
9.4%
3/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.2%
2/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Blood lactate dehydrogenase increased
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Blood potassium increased
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Haematocrit increased
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Haemoglobin increased
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Lipase increased
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
4.8%
3/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Protein total decreased
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Prothrombin time prolonged
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Red blood cell count increased
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Investigations
Weight decreased
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.3%
4/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.2%
2/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
7.9%
5/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
12.5%
2/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
18.8%
3/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.3%
4/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
18.8%
6/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
12.5%
2/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
4.8%
3/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
100.0%
3/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.2%
2/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
12.7%
8/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
9.4%
3/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.3%
4/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
4.8%
3/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Nervous system disorders
Dizziness
|
50.0%
2/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
18.8%
3/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
9/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
18.8%
6/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
4.8%
3/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
9.4%
3/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.2%
2/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
9.4%
3/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
28.6%
2/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
100.0%
3/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
9/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
12.5%
4/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Renal and urinary disorders
Dysuria
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Renal and urinary disorders
Proteinuria
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
7.9%
5/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
28.6%
18/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
34.4%
11/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
9.4%
3/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
7.9%
5/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
9.4%
3/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.2%
2/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
9.4%
3/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
4.8%
3/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
7.9%
5/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
12.5%
4/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.2%
2/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
9.4%
3/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
9.4%
3/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.2%
2/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.1%
1/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
15.6%
5/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
12.5%
2/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
1.6%
1/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
2/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.3%
4/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
53.1%
17/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
6.2%
1/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
15.9%
10/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
9.4%
3/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
66.7%
2/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
14.3%
1/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
31.2%
5/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
15.9%
10/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
28.1%
9/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
3.2%
2/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
15.6%
5/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
33.3%
1/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/7 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
0.00%
0/3 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
18.8%
3/16 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
15.9%
10/63 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
21.9%
7/32 • AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights
- Publication restrictions are in place
Restriction type: OTHER