Trial Outcomes & Findings for Combination of BI6727 (Volasertib) and BIBF1120 in Solid Tumors (NCT NCT01022853)
NCT ID: NCT01022853
Last Updated: 2018-07-30
Results Overview
DLT was defined as: 1. Drug-related CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or 4 non-haematological toxicity (except untreated vomiting, untreated nausea, or untreated diarrhoea) or 2. Drug-related CTCAE grade 4 neutropenia for 7 or more days and/or complicated by infection or 3. CTCAE grade 4 thrombocytopenia
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
28 days
Results posted on
2018-07-30
Participant Flow
An uncontrolled, open-label, dose escalation study in cohorts of patients following the '3+3 design with de-escalation'. After entering the study, cohorts of patients were sequentially allocated to the dose levels.
Beginning after the first cycle of treatment, intra-patient dose escalations were allowed and could be repeated after every cycle. Intra-patient dose escalation was not allowed after the maximum tolerated dose (MTD) was determined.
Participant milestones
| Measure |
100 mg Volasertib + 200 mg Nintedanib
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
200 mg Volasertib + 200 mg Nintedanib
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
300 mg Volasertib + 200 mg Nintedanib
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
350 mg Volasertib + 200 mg Nintedanib
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
400 mg Volasertib + 200 mg Nintedanib
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
13
|
8
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
13
|
8
|
2
|
Reasons for withdrawal
| Measure |
100 mg Volasertib + 200 mg Nintedanib
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
200 mg Volasertib + 200 mg Nintedanib
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
300 mg Volasertib + 200 mg Nintedanib
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
350 mg Volasertib + 200 mg Nintedanib
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
400 mg Volasertib + 200 mg Nintedanib
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
|
|---|---|---|---|---|---|
|
Overall Study
Progressive disease
|
2
|
3
|
11
|
7
|
1
|
|
Overall Study
Dose-limiting toxicity
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
1
|
0
|
|
Overall Study
Other not stated above
|
1
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Combination of BI6727 (Volasertib) and BIBF1120 in Solid Tumors
Baseline characteristics by cohort
| Measure |
100 mg Volasertib + 200 mg Nintedanib
n=3 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
200 mg Volasertib + 200 mg Nintedanib
n=4 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
300 mg Volasertib + 200 mg Nintedanib
n=13 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
350 mg Volasertib + 200 mg Nintedanib
n=8 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
400 mg Volasertib + 200 mg Nintedanib
n=2 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.0 years
STANDARD_DEVIATION 9.2 • n=93 Participants
|
60.0 years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
57.5 years
STANDARD_DEVIATION 8.8 • n=27 Participants
|
53.1 years
STANDARD_DEVIATION 12.9 • n=483 Participants
|
59.0 years
STANDARD_DEVIATION 5.7 • n=36 Participants
|
56.3 years
STANDARD_DEVIATION 9.6 • n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
18 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Treated set. All patients who received ≥1 dose of study medication were included in the treated set.
DLT was defined as: 1. Drug-related CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or 4 non-haematological toxicity (except untreated vomiting, untreated nausea, or untreated diarrhoea) or 2. Drug-related CTCAE grade 4 neutropenia for 7 or more days and/or complicated by infection or 3. CTCAE grade 4 thrombocytopenia
Outcome measures
| Measure |
100 mg Volasertib + 200 mg Nintedanib
n=3 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
200 mg Volasertib + 200 mg Nintedanib
n=4 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
300 mg Volasertib + 200 mg Nintedanib
n=13 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
350 mg Volasertib + 200 mg Nintedanib
n=8 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
400 mg Volasertib + 200 mg Nintedanib
n=2 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
|
Total Patients
All patients received both Volasertib and Nintedanib. Volasertib was to be infused on Day 8 in Course 1 and on Day 1 of subsequent courses, dose level varied between 100mg and 400mg. 200 mg Nintedanib was continuously administered twice daily except for the day of Volasertib administration.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD).
|
0 participants
|
0 participants
|
3 participants
|
2 participants
|
2 participants
|
—
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Treated Set. All patients who received \>= 1 dose of study medication.
The MTD was determined using a 3+3 design with de-escalation. The MTD was defined as the highest dose level at which maximal 1 out of 6 patients experienced DLT in the first course of the escalation nd de-escalation phase. However, all DLT's occurring in the trial were considered for selection of the recommended dose for further development.
Outcome measures
| Measure |
100 mg Volasertib + 200 mg Nintedanib
n=30 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
200 mg Volasertib + 200 mg Nintedanib
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
300 mg Volasertib + 200 mg Nintedanib
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
350 mg Volasertib + 200 mg Nintedanib
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
400 mg Volasertib + 200 mg Nintedanib
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
|
Total Patients
All patients received both Volasertib and Nintedanib. Volasertib was to be infused on Day 8 in Course 1 and on Day 1 of subsequent courses, dose level varied between 100mg and 400mg. 200 mg Nintedanib was continuously administered twice daily except for the day of Volasertib administration.
|
|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Volasertib in Combination With Nintedanib
|
300 mg
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first study drug administration until 28 days after the last administration of any study medication, up to 485 daysPopulation: Treated Set.
Number of participants with investigator-defined drug related adverse events.
Outcome measures
| Measure |
100 mg Volasertib + 200 mg Nintedanib
n=3 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
200 mg Volasertib + 200 mg Nintedanib
n=4 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
300 mg Volasertib + 200 mg Nintedanib
n=13 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
350 mg Volasertib + 200 mg Nintedanib
n=8 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
400 mg Volasertib + 200 mg Nintedanib
n=2 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
|
Total Patients
All patients received both Volasertib and Nintedanib. Volasertib was to be infused on Day 8 in Course 1 and on Day 1 of subsequent courses, dose level varied between 100mg and 400mg. 200 mg Nintedanib was continuously administered twice daily except for the day of Volasertib administration.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Drug Related Adverse Events
|
3 participants
|
3 participants
|
12 participants
|
7 participants
|
2 participants
|
—
|
SECONDARY outcome
Timeframe: From first study drug administration until 28 days after the last administration of any study medication, up to 485 daysPopulation: Treated Set.
Number of participants with dose limiting toxicities (DLTs). DLT was defined as: 1. Drug-related CTCAE grade 3 or 4 non-haematological toxicity (except untreated vomiting, untreated nausea, or untreated diarrhoea) or 2. Drug-related CTCAE grade 4 neutropenia for 7 or more days and/or complicated by infection or 3. CTCAE grade 4 thrombocytopenia
Outcome measures
| Measure |
100 mg Volasertib + 200 mg Nintedanib
n=3 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
200 mg Volasertib + 200 mg Nintedanib
n=4 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
300 mg Volasertib + 200 mg Nintedanib
n=13 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
350 mg Volasertib + 200 mg Nintedanib
n=8 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
400 mg Volasertib + 200 mg Nintedanib
n=2 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
|
Total Patients
All patients received both Volasertib and Nintedanib. Volasertib was to be infused on Day 8 in Course 1 and on Day 1 of subsequent courses, dose level varied between 100mg and 400mg. 200 mg Nintedanib was continuously administered twice daily except for the day of Volasertib administration.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities
|
0 participants
|
1 participants
|
6 participants
|
2 participants
|
2 participants
|
—
|
SECONDARY outcome
Timeframe: 0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusionPopulation: Pharmacokinetic (PK) analysis set. The PK analysis set included all patients who took at least 1 dose of study medication and provided at least 1 blood sample following drug administration.
Maximum measured concentration (Cmax) in plasma of Volasertib in Cycle 1.
Outcome measures
| Measure |
100 mg Volasertib + 200 mg Nintedanib
n=3 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
200 mg Volasertib + 200 mg Nintedanib
n=4 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
300 mg Volasertib + 200 mg Nintedanib
n=12 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
350 mg Volasertib + 200 mg Nintedanib
n=6 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
400 mg Volasertib + 200 mg Nintedanib
n=2 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
|
Total Patients
All patients received both Volasertib and Nintedanib. Volasertib was to be infused on Day 8 in Course 1 and on Day 1 of subsequent courses, dose level varied between 100mg and 400mg. 200 mg Nintedanib was continuously administered twice daily except for the day of Volasertib administration.
|
|---|---|---|---|---|---|---|
|
Cmax of Volasertib
|
164 ng/mL
Geometric Coefficient of Variation 77.6
|
409 ng/mL
Geometric Coefficient of Variation 23.3
|
532 ng/mL
Geometric Coefficient of Variation 33.3
|
534 ng/mL
Geometric Coefficient of Variation 25.5
|
1210 ng/mL
Geometric Coefficient of Variation 54.1
|
—
|
SECONDARY outcome
Timeframe: 0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusionPopulation: PK analysis set.
Total plasma Clearance (CL) of Volasertib in Cycle 1.
Outcome measures
| Measure |
100 mg Volasertib + 200 mg Nintedanib
n=3 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
200 mg Volasertib + 200 mg Nintedanib
n=4 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
300 mg Volasertib + 200 mg Nintedanib
n=10 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
350 mg Volasertib + 200 mg Nintedanib
n=5 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
400 mg Volasertib + 200 mg Nintedanib
n=2 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
|
Total Patients
All patients received both Volasertib and Nintedanib. Volasertib was to be infused on Day 8 in Course 1 and on Day 1 of subsequent courses, dose level varied between 100mg and 400mg. 200 mg Nintedanib was continuously administered twice daily except for the day of Volasertib administration.
|
|---|---|---|---|---|---|---|
|
CL of Volasertib
|
720 mL/min
Geometric Coefficient of Variation 19.30
|
685 mL/min
Geometric Coefficient of Variation 4.22
|
792 mL/min
Geometric Coefficient of Variation 34.2
|
849 mL/min
Geometric Coefficient of Variation 29.3
|
589 mL/min
Geometric Coefficient of Variation 18.3
|
—
|
SECONDARY outcome
Timeframe: 0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusionPopulation: PK analysis set.
Volume of distribution at steady state (Vss) of Volasertib in Cycle 1.
Outcome measures
| Measure |
100 mg Volasertib + 200 mg Nintedanib
n=3 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
200 mg Volasertib + 200 mg Nintedanib
n=4 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
300 mg Volasertib + 200 mg Nintedanib
n=10 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
350 mg Volasertib + 200 mg Nintedanib
n=5 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
400 mg Volasertib + 200 mg Nintedanib
n=2 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
|
Total Patients
All patients received both Volasertib and Nintedanib. Volasertib was to be infused on Day 8 in Course 1 and on Day 1 of subsequent courses, dose level varied between 100mg and 400mg. 200 mg Nintedanib was continuously administered twice daily except for the day of Volasertib administration.
|
|---|---|---|---|---|---|---|
|
Vss of Volasertib
|
5710 L
Geometric Coefficient of Variation 39.9
|
5590 L
Geometric Coefficient of Variation 6.53
|
5010 L
Geometric Coefficient of Variation 34.7
|
6080 L
Geometric Coefficient of Variation 21.2
|
2710 L
Geometric Coefficient of Variation 87.3
|
—
|
SECONDARY outcome
Timeframe: 5 min before Nintedanib administration in the morning and 1:00, 2:00, 3:00, 4:00, 6:00 h after administration on Day 9Population: PK analysis set.
Maximum measured concentration (Cmax) of Nintedanib in Cycle 1. 400 mg Volasertib + 200 mg Nintedanib group is not displayed due to data only being available for one patient.
Outcome measures
| Measure |
100 mg Volasertib + 200 mg Nintedanib
n=3 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
200 mg Volasertib + 200 mg Nintedanib
n=4 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
300 mg Volasertib + 200 mg Nintedanib
n=6 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
350 mg Volasertib + 200 mg Nintedanib
n=4 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
400 mg Volasertib + 200 mg Nintedanib
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
|
Total Patients
All patients received both Volasertib and Nintedanib. Volasertib was to be infused on Day 8 in Course 1 and on Day 1 of subsequent courses, dose level varied between 100mg and 400mg. 200 mg Nintedanib was continuously administered twice daily except for the day of Volasertib administration.
|
|---|---|---|---|---|---|---|
|
Cmax of Nintedanib
|
22.5 ng/mL
Geometric Coefficient of Variation 58.0
|
30.2 ng/mL
Geometric Coefficient of Variation 66.2
|
36.7 ng/mL
Geometric Coefficient of Variation 53.3
|
34.2 ng/mL
Geometric Coefficient of Variation 53.8
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 min before Nintedanib administration in the morning and 1:00, 2:00, 3:00, 4:00, 6:00 h after administration on Day 9Population: PK analysis set.
Area under the concentration-time curve (AUC) of Nintedanib over the time interval 0 to 6 hours in Cycle 1. 400 mg Volasertib + 200 mg Nintedanib group is not displayed due to data only being available for one patient.
Outcome measures
| Measure |
100 mg Volasertib + 200 mg Nintedanib
n=3 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
200 mg Volasertib + 200 mg Nintedanib
n=4 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
300 mg Volasertib + 200 mg Nintedanib
n=6 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
350 mg Volasertib + 200 mg Nintedanib
n=4 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
400 mg Volasertib + 200 mg Nintedanib
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
|
Total Patients
All patients received both Volasertib and Nintedanib. Volasertib was to be infused on Day 8 in Course 1 and on Day 1 of subsequent courses, dose level varied between 100mg and 400mg. 200 mg Nintedanib was continuously administered twice daily except for the day of Volasertib administration.
|
|---|---|---|---|---|---|---|
|
AUC(0-6h) of Nintedanib
|
69.5 ng*h/mL
Geometric Coefficient of Variation 29.9
|
104.0 ng*h/mL
Geometric Coefficient of Variation 59.4
|
135.0 ng*h/mL
Geometric Coefficient of Variation 48.8
|
121.0 ng*h/mL
Geometric Coefficient of Variation 51.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 min before Nintedanib administration in the morning and 1:00, 2:00, 3:00, 4:00, 6:00 h after administration on Day 9Population: PK analysis set.
Time from dosing to the maximum measured concentration, Cmax, of Nintedanib (tmax) in Cycle 1. 400 mg Volasertib + 200 mg Nintedanib group is not displayed due to data only being available for one patient.
Outcome measures
| Measure |
100 mg Volasertib + 200 mg Nintedanib
n=3 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
200 mg Volasertib + 200 mg Nintedanib
n=4 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
300 mg Volasertib + 200 mg Nintedanib
n=6 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
350 mg Volasertib + 200 mg Nintedanib
n=4 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
400 mg Volasertib + 200 mg Nintedanib
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
|
Total Patients
All patients received both Volasertib and Nintedanib. Volasertib was to be infused on Day 8 in Course 1 and on Day 1 of subsequent courses, dose level varied between 100mg and 400mg. 200 mg Nintedanib was continuously administered twice daily except for the day of Volasertib administration.
|
|---|---|---|---|---|---|---|
|
Tmax of Nintedanib
|
3.00 h
Interval 3.0 to 3.0
|
1.88 h
Interval 1.0 to 2.75
|
2.42 h
Interval 1.0 to 3.0
|
2.00 h
Interval 1.0 to 6.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.Population: Treated Set.
Best overall response based on response evaluation criteria in solid tumors (RECIST) version 1.1. Best overall response is defined as the best overall response (complete response, partial response, stable disease, progressive disease or not evaluable) since the start of treatment.
Outcome measures
| Measure |
100 mg Volasertib + 200 mg Nintedanib
n=3 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
200 mg Volasertib + 200 mg Nintedanib
n=4 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
300 mg Volasertib + 200 mg Nintedanib
n=13 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
350 mg Volasertib + 200 mg Nintedanib
n=8 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
400 mg Volasertib + 200 mg Nintedanib
n=2 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
|
Total Patients
All patients received both Volasertib and Nintedanib. Volasertib was to be infused on Day 8 in Course 1 and on Day 1 of subsequent courses, dose level varied between 100mg and 400mg. 200 mg Nintedanib was continuously administered twice daily except for the day of Volasertib administration.
|
|---|---|---|---|---|---|---|
|
Number of Patients With Best Overall Response
Complete Response
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Patients With Best Overall Response
Partial Response
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Patients With Best Overall Response
Stable Disease
|
2 participants
|
2 participants
|
7 participants
|
4 participants
|
1 participants
|
—
|
|
Number of Patients With Best Overall Response
Progressive Disease
|
1 participants
|
2 participants
|
3 participants
|
3 participants
|
0 participants
|
—
|
|
Number of Patients With Best Overall Response
Not Evaluable
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Patients With Best Overall Response
Missing
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.Population: Treated Set.
Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.1. OR is defined as complete response (CR) or partial response (PR) as best response throughout the study.
Outcome measures
| Measure |
100 mg Volasertib + 200 mg Nintedanib
n=3 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
200 mg Volasertib + 200 mg Nintedanib
n=4 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
300 mg Volasertib + 200 mg Nintedanib
n=13 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
350 mg Volasertib + 200 mg Nintedanib
n=8 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
400 mg Volasertib + 200 mg Nintedanib
n=2 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
|
Total Patients
All patients received both Volasertib and Nintedanib. Volasertib was to be infused on Day 8 in Course 1 and on Day 1 of subsequent courses, dose level varied between 100mg and 400mg. 200 mg Nintedanib was continuously administered twice daily except for the day of Volasertib administration.
|
|---|---|---|---|---|---|---|
|
Number of Patients With Objective Response (OR)
Objective Response (OR)
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Patients With Objective Response (OR)
Missing
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.Population: Treated Set.
Disease control based on response evaluation criteria in solid tumors (RECIST) version 1.1. Disease control is defined as complete response (CR), partial response (PR) or stable disease (SD) as best response throughout the study.
Outcome measures
| Measure |
100 mg Volasertib + 200 mg Nintedanib
n=3 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
200 mg Volasertib + 200 mg Nintedanib
n=4 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
300 mg Volasertib + 200 mg Nintedanib
n=13 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
350 mg Volasertib + 200 mg Nintedanib
n=8 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
400 mg Volasertib + 200 mg Nintedanib
n=2 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
|
Total Patients
All patients received both Volasertib and Nintedanib. Volasertib was to be infused on Day 8 in Course 1 and on Day 1 of subsequent courses, dose level varied between 100mg and 400mg. 200 mg Nintedanib was continuously administered twice daily except for the day of Volasertib administration.
|
|---|---|---|---|---|---|---|
|
Number of Patients With Disease Control
|
2 participants
|
2 participants
|
9 participants
|
4 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.Population: All patients of the treated set that were assessed to show disease control.
Disease control based on response evaluation criteria in solid tumors (RECIST) version 1.1. Patients who had a best overall tumour response of complete response (CR), partial response (PR) or stable disease (SD) were assessed to show disease control.
Outcome measures
| Measure |
100 mg Volasertib + 200 mg Nintedanib
n=2 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
200 mg Volasertib + 200 mg Nintedanib
n=2 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
300 mg Volasertib + 200 mg Nintedanib
n=9 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
350 mg Volasertib + 200 mg Nintedanib
n=4 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
400 mg Volasertib + 200 mg Nintedanib
n=1 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
|
Total Patients
n=18 Participants
All patients received both Volasertib and Nintedanib. Volasertib was to be infused on Day 8 in Course 1 and on Day 1 of subsequent courses, dose level varied between 100mg and 400mg. 200 mg Nintedanib was continuously administered twice daily except for the day of Volasertib administration.
|
|---|---|---|---|---|---|---|
|
Duration of Disease Control
|
163.0 days
Interval 114.0 to 212.0
|
348.0 days
Interval 184.0 to 512.0
|
141.0 days
Interval 74.0 to 447.0
|
215.0 days
Interval 94.0 to 394.0
|
56.0 days
Interval 56.0 to 56.0
|
161.5 days
Interval 56.0 to 512.0
|
SECONDARY outcome
Timeframe: Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.Population: Treated Set.
PFS is defined as the time from start of treatment with study medication to tumour progression or death whichever occurs first. Tumour response was to be documented using appropriate techniques such as magnetic resonance imaging (MRI) or computer tomography (CT).
Outcome measures
| Measure |
100 mg Volasertib + 200 mg Nintedanib
n=3 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
200 mg Volasertib + 200 mg Nintedanib
n=4 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
300 mg Volasertib + 200 mg Nintedanib
n=13 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
350 mg Volasertib + 200 mg Nintedanib
n=8 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
400 mg Volasertib + 200 mg Nintedanib
n=2 Participants
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
|
Total Patients
n=30 Participants
All patients received both Volasertib and Nintedanib. Volasertib was to be infused on Day 8 in Course 1 and on Day 1 of subsequent courses, dose level varied between 100mg and 400mg. 200 mg Nintedanib was continuously administered twice daily except for the day of Volasertib administration.
|
|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
114.0 days
Interval 45.0 to 212.0
|
116.0 days
Interval 35.0 to 512.0
|
99.0 days
Interval 30.0 to 447.0
|
72.5 days
Interval 8.0 to 394.0
|
83.0 days
Interval 56.0 to 110.0
|
96.5 days
Interval 8.0 to 512.0
|
Adverse Events
100 mg Volasertib + 200 mg Nintedanib
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
200 mg Volasertib + 200 mg Nintedanib
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
300 mg Volasertib + 200 mg Nintedanib
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
350 mg Volasertib + 200 mg Nintedanib
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
400 mg Volasertib + 200 mg Nintedanib
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
100 mg Volasertib + 200 mg Nintedanib
n=3 participants at risk
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
200 mg Volasertib + 200 mg Nintedanib
n=4 participants at risk
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
300 mg Volasertib + 200 mg Nintedanib
n=13 participants at risk
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
350 mg Volasertib + 200 mg Nintedanib
n=8 participants at risk
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
400 mg Volasertib + 200 mg Nintedanib
n=2 participants at risk
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Renal and urinary disorders
Bladder obstruction
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
Other adverse events
| Measure |
100 mg Volasertib + 200 mg Nintedanib
n=3 participants at risk
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 100 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
200 mg Volasertib + 200 mg Nintedanib
n=4 participants at risk
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 200 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
300 mg Volasertib + 200 mg Nintedanib
n=13 participants at risk
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 300 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
350 mg Volasertib + 200 mg Nintedanib
n=8 participants at risk
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 350 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
Course 2 and subsequent courses comprised 21 days. Volasertib was infused on Day 1 and continuous nintedanib administration re-started on Day 2.
|
400 mg Volasertib + 200 mg Nintedanib
n=2 participants at risk
Course 1 comprised of 28 days because of a 7-day run-in period for nintedanib (200 mg twice daily). The treatment with nintedanib started on Day 1 of Course 1 and continued until the end of the course. 400 mg volasertib was infused on Day 8 of Course 1; no nintedanib was to be taken on that day.
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Renal and urinary disorders
Pollakiuria
|
33.3%
1/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
30.8%
4/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
2/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
100.0%
2/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
30.8%
4/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
100.0%
2/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
69.2%
9/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
4/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
61.5%
8/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
62.5%
5/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Ear and labyrinth disorders
Vertigo
|
33.3%
1/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
15.4%
2/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
75.0%
3/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
2/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
15.4%
2/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
37.5%
3/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
61.5%
8/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
4/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
30.8%
4/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
15.4%
2/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
2/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
30.8%
4/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
75.0%
6/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
2/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
2/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
46.2%
6/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
37.5%
3/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
100.0%
2/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
General disorders
Asthenia
|
66.7%
2/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
2/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
61.5%
8/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
62.5%
5/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
100.0%
2/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
General disorders
Chest pain
|
100.0%
3/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
General disorders
Chills
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
General disorders
Fatigue
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
15.4%
2/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
2/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
38.5%
5/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
4/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Infections and infestations
Viral uveitis
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
53.8%
7/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
2/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
53.8%
7/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
15.4%
2/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
2/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Investigations
Glomerular filtration rate increased
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
2/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
15.4%
2/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
2/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
15.4%
2/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
15.4%
2/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
33.3%
1/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
2/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
33.3%
1/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
23.1%
3/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
2/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
15.4%
2/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
23.1%
3/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
37.5%
3/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
15.4%
2/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
37.5%
3/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
33.3%
1/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary microemboli
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
15.4%
2/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
7.7%
1/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
1/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
12.5%
1/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
2/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
15.4%
2/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
25.0%
2/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
50.0%
1/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/4 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
15.4%
2/13 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/8 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
0.00%
0/2 • All adverse events (AEs) that occurred during therapy with the study medication, or within 28 days after the last administration of any study medication, up to 485 days
Patients were asked for spontaneous reports about AEs; detailed information was collected by specific questions.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
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