Trial Outcomes & Findings for Phase I/II Comparison of Efficacy and Safety of BIBF 1120 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma (NCT NCT01004003)
NCT ID: NCT01004003
Last Updated: 2017-10-26
Results Overview
The MTD was defined as the highest dose studied for which the incidence of dose limiting toxicities (DLTs) was 0/3 or less than 2/6 patients during the first treatment course.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
125 participants
Primary outcome timeframe
4 weeks
Results posted on
2017-10-26
Participant Flow
Participant milestones
| Measure |
Phase 1 Group 1, 100mg 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). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤2 times the upper limit of normal (ULN).
|
Phase I Group 1, 150mg 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. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
Phase I Group 1, 200mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
Phase I Group 2, 50mg 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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 100mg 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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 150mg 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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 200mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase II, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
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 macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
4
|
3
|
4
|
4
|
8
|
62
|
31
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
4
|
3
|
4
|
4
|
8
|
60
|
30
|
Reasons for withdrawal
| Measure |
Phase 1 Group 1, 100mg 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). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤2 times the upper limit of normal (ULN).
|
Phase I Group 1, 150mg 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. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
Phase I Group 1, 200mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
Phase I Group 2, 50mg 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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 100mg 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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 150mg 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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 200mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase II, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
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 macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Progressive disease
|
2
|
1
|
1
|
0
|
2
|
1
|
1
|
39
|
22
|
|
Overall Study
Adverse Event
|
4
|
2
|
3
|
3
|
2
|
2
|
7
|
21
|
6
|
|
Overall Study
Refused to continue taking trial med.
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Phase I/II Comparison of Efficacy and Safety of BIBF 1120 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Baseline characteristics by cohort
| Measure |
Phase 1 Group 1, 100mg 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 maximal tolerated dose (MTD). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤2 times the upper limit of normal (ULN).
|
Phase I Group 1, 150mg 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. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
Phase I Group 1, 200mg Nintedanib Bid
n=4 Participants
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
Phase I Group 2, 50mg 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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 100mg 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 MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 150mg Nintedanib Bid
n=4 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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 200mg Nintedanib Bid
n=8 Participants
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase II, 200 mg Nintedanib Bid
n=62 Participants
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
Phase II, 400 mg Sorafenib Bid
n=31 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 macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.7 Years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
65.0 Years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
66.5 Years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
72.3 Years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
56.3 Years
STANDARD_DEVIATION 6.4 • n=21 Participants
|
59.3 Years
STANDARD_DEVIATION 13.9 • n=10 Participants
|
57.0 Years
STANDARD_DEVIATION 11.0 • n=115 Participants
|
65.4 Years
STANDARD_DEVIATION 10.0 • n=24 Participants
|
63.1 Years
STANDARD_DEVIATION 11.8 • n=42 Participants
|
64.2 Years
STANDARD_DEVIATION 10.5 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
14 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
48 Participants
n=24 Participants
|
26 Participants
n=42 Participants
|
101 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Treated set which included all patients who received at least one single dose of trial medication, including phase I 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 dose limiting toxicities (DLTs) was 0/3 or less than 2/6 patients during the first treatment course.
Outcome measures
| Measure |
Group 1
n=9 Participants
Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)
|
Group 2
n=13 Participants
Patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 1, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg)twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose in Phase I
|
200 mg bid
|
200 mg bid
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From randomization until data cut-off (15 July 2014); Up to 1031 daysPopulation: 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=62 Participants
Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)
|
Group 2
n=31 Participants
Patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 1, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg)twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
|---|---|---|---|---|---|---|---|
|
Time to Progression (TTP) in Phase II
|
5.45 months
Interval 2.69 to 9.2
|
4.63 months
Interval 2.79 to 20.4
|
—
|
—
|
—
|
—
|
—
|
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 had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)
|
Group 2
n=3 Participants
Patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 1, 200 mg Nintedanib Bid
n=3 Participants
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 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 MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 200 mg Nintedanib Bid
n=3 Participants
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg)twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
|---|---|---|---|---|---|---|---|
|
Incidence of Dose Limiting Toxicity in Phase I
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From randomization until data cut-off (15 July 2014); Up to 1031 daysPopulation: Treated set, phase II participants only
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=62 Participants
Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)
|
Group 2
n=31 Participants
Patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 1, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg)twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
|---|---|---|---|---|---|---|---|
|
Objective Tumour Response by RECIST
|
1.6 percentage of participants
Interval 0.0 to 8.7
|
6.5 percentage of participants
Interval 0.8 to 21.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization until data cut-off (15 July 2014); Up to 1031 daysPopulation: 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=62 Participants
Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)
|
Group 2
n=31 Participants
Patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 1, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg)twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
5.32 months
Interval 2.69 to 9.2
|
3.94 months
Interval 2.33 to 7.36
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization until data cut-off (15 July 2014); Up to 1031 daysPopulation: Treated set, 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=62 Participants
Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)
|
Group 2
n=31 Participants
Patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 1, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 200 mg Nintedanib Bid
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg)twice daily (bid).
Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
|---|---|---|---|---|---|---|---|
|
Overall Survival
|
11.86 months
Interval 6.6 to 25.46
|
11.40 months
Interval 6.51 to 17.25
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1 Group 1, 100mg Nintedanib Bid
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase I Group 1, 150mg Nintedanib Bid
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I Group 1, 200mg Nintedanib Bid
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase I Group 2, 50mg Nintedanib Bid
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I Group 2, 100mg Nintedanib Bid
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase I Group 2, 150mg Nintedanib Bid
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase I Group 2, 200mg Nintedanib Bid
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase II, 200 mg Nintedanib Bid
Serious events: 34 serious events
Other events: 61 other events
Deaths: 0 deaths
Phase II, 400 mg Sorafenib Bid
Serious events: 14 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 Group 1, 100mg Nintedanib Bid
n=6 participants at risk
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). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤2 times the upper limit of normal (ULN).
|
Phase I Group 1, 150mg Nintedanib Bid
n=3 participants at risk
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. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
Phase I Group 1, 200mg Nintedanib Bid
n=4 participants at risk
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
Phase I Group 2, 50mg Nintedanib Bid
n=3 participants at risk
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 100mg Nintedanib Bid
n=4 participants at risk
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 150mg Nintedanib Bid
n=4 participants at risk
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 200mg Nintedanib Bid
n=8 participants at risk
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase II, 200 mg Nintedanib Bid
n=62 participants at risk
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
Phase II, 400 mg Sorafenib Bid
n=31 participants at risk
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 macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
4.8%
3/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Blood and lymphatic system disorders
Splenic vein thrombosis
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Eye disorders
Glaucoma
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Eye disorders
Retinal detachment
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
66.7%
2/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Ascites
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
66.7%
2/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
50.0%
2/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
50.0%
2/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Chest pain
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Disease progression
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Fatigue
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
4.8%
3/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
General physical health deterioration
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Impaired healing
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Multi-organ failure
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Performance status decreased
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Infections and infestations
Ludwig angina
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Investigations
Lipase increased
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
50.0%
2/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
3/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour thrombosis
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
8.1%
5/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Psychiatric disorders
Confusional state
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Surgical and medical procedures
Hepatectomy
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
Other adverse events
| Measure |
Phase 1 Group 1, 100mg Nintedanib Bid
n=6 participants at risk
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). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤2 times the upper limit of normal (ULN).
|
Phase I Group 1, 150mg Nintedanib Bid
n=3 participants at risk
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. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
Phase I Group 1, 200mg Nintedanib Bid
n=4 participants at risk
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
Phase I Group 2, 50mg Nintedanib Bid
n=3 participants at risk
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 100mg Nintedanib Bid
n=4 participants at risk
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 150mg Nintedanib Bid
n=4 participants at risk
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. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase I Group 2, 200mg Nintedanib Bid
n=8 participants at risk
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT \>2 to ≤5 times ULN.
|
Phase II, 200 mg Nintedanib Bid
n=62 participants at risk
Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
Phase II, 400 mg Sorafenib Bid
n=31 participants at risk
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 macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
8.1%
5/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.9%
4/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Ear and labyrinth disorders
Cerumen impaction
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Ear and labyrinth disorders
Deafness
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
4/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Eye disorders
Eye discharge
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
75.0%
3/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
3/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
50.0%
2/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
37.5%
3/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
24.2%
15/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
29.0%
9/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Abdominal pain lower
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
4.8%
3/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
50.0%
2/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
50.0%
2/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
2/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.8%
16/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.9%
4/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Anorectal varices
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
4.8%
3/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
50.0%
2/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
14.5%
9/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
19.4%
6/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
66.7%
2/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
75.0%
3/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
100.0%
3/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
50.0%
2/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
75.0%
3/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
62.5%
5/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
69.4%
43/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
67.7%
21/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
3/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
66.7%
2/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
3/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
4/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
3/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
2/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
100.0%
3/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
75.0%
3/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
66.7%
2/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
75.0%
3/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
87.5%
7/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
46.8%
29/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
29.0%
9/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
3/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Toothache
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
100.0%
3/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
75.0%
3/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
66.7%
2/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
50.0%
2/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
62.5%
5/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
37.1%
23/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
29.0%
9/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Asthenia
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
4.8%
3/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Catheter site bruise
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Chest pain
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Chills
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
4.8%
3/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Device difficult to use
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Fatigue
|
50.0%
3/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
75.0%
3/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
66.7%
2/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
50.0%
2/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
62.5%
5/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
51.6%
32/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
32.3%
10/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Feeling cold
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Gait disturbance
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
General physical health deterioration
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Impaired healing
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Inflammation
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Influenza like illness
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
75.0%
3/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Injection site bruising
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Local swelling
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Malaise
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Mucosal inflammation
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
3/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Oedema
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
4/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
2/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.9%
8/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Pain
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
General disorders
Pyrexia
|
33.3%
2/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
16.1%
10/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
3/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
50.0%
2/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
50.0%
2/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
4/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
3/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
6/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
4/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Infections and infestations
Tooth abscess
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
3/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
4.8%
3/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.9%
8/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
3/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Investigations
Amylase increased
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
50.0%
2/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
66.7%
2/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
2/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
17.7%
11/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
16.1%
5/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Investigations
Blood albumin decreased
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
66.7%
2/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
6/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Investigations
Blood bilirubin increased
|
33.3%
2/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
2/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.9%
8/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
19.4%
6/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Investigations
Blood potassium decreased
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
4/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Investigations
International normalised ratio increased
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Investigations
Lipase increased
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Investigations
Liver function test abnormal
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Investigations
Weight decreased
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.9%
8/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
75.0%
3/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
50.0%
2/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
50.0%
2/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
62.5%
5/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
37.1%
23/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
41.9%
13/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
4/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
66.7%
2/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
6/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
3/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
4.8%
3/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
3/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
11.3%
7/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
4.8%
3/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
4.8%
3/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Nervous system disorders
Aphonia
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
6/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
3/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
50.0%
2/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
50.0%
2/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
4/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
3/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Nervous system disorders
Dyskinesia
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
2/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.9%
8/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
16.1%
5/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
50.0%
2/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
8.1%
5/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.8%
8/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Psychiatric disorders
Confusional state
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Psychiatric disorders
Depressed mood
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
8.1%
5/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
66.7%
2/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
4.8%
3/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Renal and urinary disorders
Chromaturia
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Renal and urinary disorders
Urinary incontinence
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
50.0%
2/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
50.0%
2/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
2/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
4.8%
3/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
4/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
4.8%
3/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
11.3%
7/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
3/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of bronchial secretion
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
4.8%
3/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
35.5%
11/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
4/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
16.1%
5/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
4.8%
3/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
3/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
2/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
6.5%
2/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
35.5%
11/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
50.0%
2/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
14.5%
9/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
3/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
6/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
22.6%
7/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
3/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
11.3%
7/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
9.7%
3/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
25.0%
1/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
12.5%
1/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
1.6%
1/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
3.2%
1/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
|
Vascular disorders
Intra-abdominal haematoma
|
0.00%
0/6 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
33.3%
1/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/3 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/4 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/8 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/62 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 days
|
0.00%
0/31 • From first administration of the trial drug and until 28 days after the last administration of nintedanib or sorafenib, up to 1289 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