Trial Outcomes & Findings for Phase I Dose Escalation of i.v. BI 836909 Monotherapy in Last Line Multiple Myeloma Patients (NCT NCT02514239)
NCT ID: NCT02514239
Last Updated: 2022-02-24
Results Overview
The Maximum tolerated dose (MTD) of BI 836909, which was defined as the highest dose of the dose level tested where ≤1 patient out of 6 developed a Dose-limiting toxicity (DLT). The MTD was defined based on DLTs observed during Cycle 1. However, all Adverse Events corresponding to the definition of a DLT (see below) were to be considered for confirming the MTD. A DLT was defined as any drug-related non-haematological Adverse Event of Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grade 3 or higher.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
43 participants
Primary outcome timeframe
Cycle 1, up to 6 weeks.
Results posted on
2022-02-24
Participant Flow
This was an open-label, non-randomised, phase I, dose escalation trial in patients with relapsed and/or refractory multiple myeloma. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were to be tested in a 3+3 design. Once the Maximum tolerated dose (MTD) was determined, up to 6 additional patients were to be treated at the MTD or at the recommended dose.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)
Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (6.5 μg/d)
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (50 μg/d)
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (100 μg/d)
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
3
|
3
|
3
|
5
|
4
|
3
|
10
|
3
|
|
Overall Study
Treated
|
5
|
3
|
3
|
3
|
3
|
5
|
4
|
3
|
10
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
2
|
3
|
3
|
4
|
4
|
3
|
8
|
3
|
Reasons for withdrawal
| Measure |
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)
Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (6.5 μg/d)
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (50 μg/d)
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (100 μg/d)
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Refused to continue trial medication
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Dose-limiting toxicity (DLT)
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Overall Study
Not treated
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other Adverse Events
|
2
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
2
|
0
|
|
Overall Study
Progressive disease
|
3
|
3
|
2
|
2
|
3
|
3
|
4
|
2
|
5
|
0
|
Baseline Characteristics
Phase I Dose Escalation of i.v. BI 836909 Monotherapy in Last Line Multiple Myeloma Patients
Baseline characteristics by cohort
| Measure |
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)
n=5 Participants
Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (3.2 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (6.5 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (13 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (25 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (50 μg/d)
n=5 Participants
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (100 μg/d)
n=4 Participants
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
n=10 Participants
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 12.3 • n=99 Participants
|
67.7 years
STANDARD_DEVIATION 2.5 • n=107 Participants
|
63.0 years
STANDARD_DEVIATION 9.8 • n=206 Participants
|
69.3 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
67.0 years
STANDARD_DEVIATION 7.5 • n=31 Participants
|
61.6 years
STANDARD_DEVIATION 4.6 • n=30 Participants
|
62.5 years
STANDARD_DEVIATION 7.8 • n=3 Participants
|
62.7 years
STANDARD_DEVIATION 14.5 • n=6 Participants
|
57.7 years
STANDARD_DEVIATION 12.2 • n=114 Participants
|
71.3 years
STANDARD_DEVIATION 8.6
|
62.6 years
STANDARD_DEVIATION 9.9 • n=19 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
3 Participants
|
15 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
7 Participants
n=114 Participants
|
0 Participants
|
27 Participants
n=19 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
8 Participants
n=114 Participants
|
2 Participants
|
28 Participants
n=19 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
1 Participants
|
14 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Cycle 1, up to 6 weeks.Population: MTD evaluation set (MTDS): all patients who were administered trial medication and who were not replaced for the Maximum tolerated dose (MTD) determination.
The Maximum tolerated dose (MTD) of BI 836909, which was defined as the highest dose of the dose level tested where ≤1 patient out of 6 developed a Dose-limiting toxicity (DLT). The MTD was defined based on DLTs observed during Cycle 1. However, all Adverse Events corresponding to the definition of a DLT (see below) were to be considered for confirming the MTD. A DLT was defined as any drug-related non-haematological Adverse Event of Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grade 3 or higher.
Outcome measures
| Measure |
Intravenous Infusion of BI 836909 (Total Dose Escalation)
n=34 Participants
BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.
|
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (6.5 μg/d)
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (50 μg/d)
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (100 μg/d)
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Maximum Tolerated Dose (MTD) of BI 836909
|
400 Microgram Per Day (μg/d)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1, up to 6 weeks.Population: MTD evaluation set (MTDS): all patients who were administered trial medication and who were not replaced for the Maximum tolerated dose (MTD) determination.
The number of patients with Dose-limiting toxicities (DLTs) in cycle 1. A Dose-limiting toxicity was defined as any drug-related non-haematological Adverse Event of Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grade 3 or higher.
Outcome measures
| Measure |
Intravenous Infusion of BI 836909 (Total Dose Escalation)
n=4 Participants
BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.
|
Intravenous Infusion of BI 836909 (3.2 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (6.5 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (13 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (25 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (50 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (100 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
n=6 Participants
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Number of Patients With Dose-limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On-treatment: From start of treatment till end of trial (EOT) visit, up to 61 weeks. Extended follow-up: From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.Population: Treated set (TS): all patients who were administered trial medication.
Objective responses: Stringent complete response (sCR): CR + normal Free light chain (FLC) ratio and no clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR: negative immunofixation on serum and urine, disappearance of soft tissue plasmacytomas, and \<5% plasma cells in bone marrow. Very good partial response (VGPR): serum and urine M protein detectable by immunofixation but not on electrophoresis or \>90% reduction in serum M protein plus urine M protein level \<100 mg/24h. PR: \>50% reduction of serum and 24 h urinary M protein by \>90% or to \<200mg/24h. If unmeasurable, a \>50% decrease in difference between involved and uninvolved FLC levels instead of M protein criteria. if FLC assay was not measurable, a \>50% reduction in plasma cells was required instead of M protein, provided baseline bone marrow plasma cell was \>30%. In addition to the listed criteria, a \>50% reduction in the size of soft tissue plasmacytomas was also required, if present at baseline.
Outcome measures
| Measure |
Intravenous Infusion of BI 836909 (Total Dose Escalation)
n=5 Participants
BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.
|
Intravenous Infusion of BI 836909 (3.2 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (6.5 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (13 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (25 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (50 μg/d)
n=5 Participants
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (100 μg/d)
n=4 Participants
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
n=10 Participants
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With an Objective Response
On treatment · Stringent complete response (sCR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With an Objective Response
On treatment · Complete response (CR)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With an Objective Response
On treatment · Very good partial response (VGPR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With an Objective Response
On treatment · Partial response (PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With an Objective Response
On treatment · No response (stable disease or disease progression)
|
5 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With an Objective Response
On treatment + extended follow-up visits (follow-up · Stringent complete response (sCR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With an Objective Response
On treatment + extended follow-up visits (follow-up · Complete response (CR)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With an Objective Response
On treatment + extended follow-up visits (follow-up · Very good partial response (VGPR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With an Objective Response
On treatment + extended follow-up visits (follow-up · Partial response (PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With an Objective Response
On treatment + extended follow-up visits (follow-up · No response (stable disease or disease progression)
|
5 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment till end of trial (EOT) visit, up to 61 weeks.Population: All patients who were administered trial medication and showed an objective response.
For patients with objective response, the duration of response was calculated from the time of first recorded achievement of a response (sCR, CR, PR, or VGPR) until documented progression or death. The Kaplan-Meier method was used to calculate the estimates.
Outcome measures
| Measure |
Intravenous Infusion of BI 836909 (Total Dose Escalation)
BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.
|
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (6.5 μg/d)
n=1 Participants
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (50 μg/d)
n=1 Participants
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (100 μg/d)
n=1 Participants
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
n=1 Participants
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
n=7 Participants
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
n=2 Participants
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Objective Response - on Treatment
|
—
|
—
|
NA Months
Insufficient number of participants with events.
|
—
|
—
|
NA Months
Insufficient number of participants with events.
|
NA Months
Insufficient number of participants with events.
|
NA Months
Insufficient number of participants with events.
|
NA Months
Interval 4.63 to
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
|
NA Months
Insufficient number of participants with events.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment till the last extended follow-up visit which is scheduled at 12 months after end of treatment, up to 113 weeks.Population: All patients who were administered trial medication and showed an objective response.
For patients with objective response, the duration of response was calculated from the time of first recorded achievement of a response (sCR, CR, PR, or VGPR) until documented progression or death. The Kaplan-Meier method was used to calculate the estimates.
Outcome measures
| Measure |
Intravenous Infusion of BI 836909 (Total Dose Escalation)
BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.
|
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (6.5 μg/d)
n=1 Participants
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (50 μg/d)
n=1 Participants
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (100 μg/d)
n=1 Participants
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
n=1 Participants
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
n=7 Participants
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
n=2 Participants
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Objective Response - Including Extended Follow up Visits
|
—
|
—
|
NA Months
Insufficient number of participants with events.
|
—
|
—
|
NA Months
Insufficient number of participants with events.
|
NA Months
Insufficient number of participants with events.
|
NA Months
Insufficient number of participants with events.
|
23.62 Months
Interval 4.63 to 24.18
|
NA Months
Insufficient number of participants with events.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On-treatment: From start of treatment till end of trial (EOT) visit, up to 61 weeks. Follow-up: From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.Population: Treated set (TS): all patients who were administered trial medication.
Minimal residual disease (MRD) response was defined as \<1 tumour cell within 10000 normal cells in bone marrow. MRD was determined using Fluorescence-activated cell sorting (FACS) analysis.
Outcome measures
| Measure |
Intravenous Infusion of BI 836909 (Total Dose Escalation)
n=5 Participants
BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.
|
Intravenous Infusion of BI 836909 (3.2 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (6.5 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (13 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (25 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (50 μg/d)
n=5 Participants
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (100 μg/d)
n=4 Participants
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
n=10 Participants
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Minimal Residual Disease (MRD) Response
On treatment
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With a Minimal Residual Disease (MRD) Response
On treatment + extended follow-up visits (follow-up)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment till end of trial (EOT) visit, up to 61 weeks.Population: All patients who were administered trial medication and showed a Minimal residual disease (MRD) response.
Duration of MRD response was calculated from the time of first recorded achievement of a MRD response to documented progression or death. The Kaplan-Meier method was used to calculate the estimates.
Outcome measures
| Measure |
Intravenous Infusion of BI 836909 (Total Dose Escalation)
BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.
|
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (6.5 μg/d)
n=1 Participants
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (50 μg/d)
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (100 μg/d)
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
n=1 Participants
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
n=6 Participants
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Minimal Residual Disease (MRD) Response - on Treatment
|
—
|
—
|
NA Months
Insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
NA Months
Insufficient number of participants with events.
|
NA Months
Interval 9.0 to
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.Population: All patients who were administered trial medication and showed a Minimal residual disease (MRD) response.
Duration of MRD response was calculated from the time of first recorded achievement of a MRD response to documented progression or death. The Kaplan-Meier method was used to calculate the estimates.
Outcome measures
| Measure |
Intravenous Infusion of BI 836909 (Total Dose Escalation)
BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.
|
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (6.5 μg/d)
n=1 Participants
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (50 μg/d)
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (100 μg/d)
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
n=1 Participants
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
n=6 Participants
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Minimal Residual Disease (MRD) Response - Including Extended Follow up Visits
|
—
|
—
|
NA Months
Insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
NA Months
Insufficient number of participants with events.
|
20.70 Months
Interval 9.0 to 22.77
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment till end of trial (EOT) visit, up to 61 weeks.Population: Treated set (TS): all patients who were administered trial medication.
PFS was defined as time from first treatment with BI 836909 till disease progression or death. Progression was defined according to International Myeloma Working Group (IMWG 2006) response criteria as an increase \>25% from lowest response value in any of the following parameters: -Serum M protein (absolute increase had to be \>0.5 gram/ deciliters (dL)) -Urine M protein (absolute increase had to be \>200 milligram (mg)/24 hour) -Only in patients without measurable serum and urine M protein levels The difference between involved and uninvolved FLC levels. Absolute increase had to be \>10 mg/dL -Bone marrow plasma cell percentage; absolute percentage had to be \>10% -Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas -Development of hypercalcaemia (corrected serum calcium \>11.5 mg/dL or 2.65 Millimole/Liter) that was attributed solely to the plasma cell proliferative disorder.
Outcome measures
| Measure |
Intravenous Infusion of BI 836909 (Total Dose Escalation)
n=5 Participants
BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.
|
Intravenous Infusion of BI 836909 (3.2 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (6.5 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (13 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (25 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (50 μg/d)
n=5 Participants
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (100 μg/d)
n=4 Participants
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
n=10 Participants
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) - on Treatment
|
NA Months
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
|
NA Months
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
|
NA Months
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
|
NA Months
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
|
NA Months
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
|
NA Months
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
|
NA Months
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
|
NA Months
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
|
5.55 Months
Interval 0.95 to
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
|
NA Months
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.Population: Treated set (TS): all patients who were administered trial medication.
PFS was defined as time from first treatment with BI 836909 till disease progression or death. Progression was defined according to International Myeloma Working Group (IMWG 2006) response criteria as an increase \>25% from lowest response value in any of the following parameters: -Serum M protein (absolute increase had to be \>0.5 gram/ deciliters (dL)) -Urine M protein (absolute increase had to be \>200 milligram (mg)/24 hour) -Only in patients without measurable serum and urine M protein levels The difference between involved and uninvolved FLC levels. Absolute increase had to be \>10 mg/dL -Bone marrow plasma cell percentage; absolute percentage had to be \>10% -Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas -Development of hypercalcaemia (corrected serum calcium \>11.5 mg/dL or 2.65 Millimole/Liter) that was attributed solely to the plasma cell proliferative disorder
Outcome measures
| Measure |
Intravenous Infusion of BI 836909 (Total Dose Escalation)
n=5 Participants
BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.
|
Intravenous Infusion of BI 836909 (3.2 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (6.5 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (13 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (25 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (50 μg/d)
n=5 Participants
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (100 μg/d)
n=4 Participants
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
n=10 Participants
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) - Including Extended Follow up Visits
|
NA Months
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
|
NA Months
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
|
NA Months
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
|
NA Months
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
|
NA Months
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
|
NA Months
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
|
NA Months
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
|
NA Months
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
|
7.74 Months
Interval 0.95 to 24.41
|
NA Months
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected at 48:00 hours (h):minutes (min), 168:00, 336:00, 504:00 and 671:50 h after the start of infusion of BI 836909 of the first cycle.Population: PK Analysis Set (PKS): all evaluable patients in the treated set which provide at least one evaluable observation for at least one PK endpoint.
Serum concentration at steady state of BI 836909 (Css).
Outcome measures
| Measure |
Intravenous Infusion of BI 836909 (Total Dose Escalation)
n=1 Participants
BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.
|
Intravenous Infusion of BI 836909 (3.2 μg/d)
n=1 Participants
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (6.5 μg/d)
n=2 Participants
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (13 μg/d)
n=1 Participants
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (25 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (50 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (100 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
n=5 Participants
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
n=4 Participants
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
n=3 Participants
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
n=9 Participants
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
n=2 Participants
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum Concentration at Steady State of BI 836909 (Css)
|
NA picogram/milliliter (pg/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation could not be calculated because the serum concentrations of BI 836909 were below limit of quantitation (BLQ) for 0.2 ug/day.
|
86.5 picogram/milliliter (pg/mL)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated because of the limited sample size.
|
90.8 picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 41.1
|
184 picogram/milliliter (pg/mL)
Geometric Coefficient of Variation NA
Geometric Coefficient of Variation could not be calculated because of the limited sample size.
|
526 picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 34.7
|
1070 picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 67.3
|
2180 picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 34.6
|
4130 picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 30.7
|
10700 picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 55.4
|
9810 picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 47.6
|
14100 picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 121
|
29900 picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 54.3
|
33000 picogram/milliliter (pg/mL)
Geometric Coefficient of Variation 41.0
|
Adverse Events
Intravenous Infusion of BI 836909 (0.2 μg/d)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Intravenous Infusion of BI 836909 (0.4 μg/d)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Intravenous Infusion of BI 836909 (0.8 μg/d)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Intravenous Infusion of BI 836909 (1.6 μg/d)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Intravenous Infusion of BI 836909 (3.2 μg/d)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Intravenous Infusion of BI 836909 (6.5 μg/d)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Intravenous Infusion of BI 836909 (13 μg/d)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Intravenous Infusion of BI 836909 (25 μg/d)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Intravenous Infusion of BI 836909 (50 μg/d)
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
Intravenous Infusion of BI 836909 (100 μg/d)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Intravenous Infusion of BI 836909 (200 μg/d)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Intravenous Infusion of BI 836909 (400 μg/d)
Serious events: 8 serious events
Other events: 10 other events
Deaths: 1 deaths
Intravenous Infusion of BI 836909 (800 μg/d)
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Intravenous Infusion of BI 836909 (Total Dose Escalation)
Serious events: 27 serious events
Other events: 40 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Intravenous Infusion of BI 836909 (0.2 μg/d)
n=1 participants at risk
Intravenous infusion of BI 836909 (0.2 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (0.4 μg/d)
n=1 participants at risk
Intravenous infusion of BI 836909 (0.4 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (0.8 μg/d)
n=2 participants at risk
Intravenous infusion of BI 836909 (0.8 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (1.6 μg/d)
n=1 participants at risk
Intravenous infusion of BI 836909 (1.6 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (3.2 μg/d)
n=3 participants at risk
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (6.5 μg/d)
n=3 participants at risk
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (13 μg/d)
n=3 participants at risk
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (25 μg/d)
n=3 participants at risk
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (50 μg/d)
n=5 participants at risk
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (100 μg/d)
n=4 participants at risk
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
n=3 participants at risk
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
n=10 participants at risk
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
n=3 participants at risk
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (Total Dose Escalation)
n=42 participants at risk
BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
General disorders
Disease progression
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
General disorders
Generalised oedema
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
50.0%
1/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
30.0%
3/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
11.9%
5/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Device related infection
|
100.0%
1/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Infection
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Influenza
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Lung infection
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
2/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
11.9%
5/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
9.5%
4/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
Other adverse events
| Measure |
Intravenous Infusion of BI 836909 (0.2 μg/d)
n=1 participants at risk
Intravenous infusion of BI 836909 (0.2 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (0.4 μg/d)
n=1 participants at risk
Intravenous infusion of BI 836909 (0.4 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (0.8 μg/d)
n=2 participants at risk
Intravenous infusion of BI 836909 (0.8 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (1.6 μg/d)
n=1 participants at risk
Intravenous infusion of BI 836909 (1.6 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (3.2 μg/d)
n=3 participants at risk
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (6.5 μg/d)
n=3 participants at risk
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (13 μg/d)
n=3 participants at risk
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (25 μg/d)
n=3 participants at risk
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (50 μg/d)
n=5 participants at risk
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (100 μg/d)
n=4 participants at risk
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (200 μg/d)
n=3 participants at risk
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (400 μg/d)
n=10 participants at risk
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (800 μg/d)
n=3 participants at risk
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
|
Intravenous Infusion of BI 836909 (Total Dose Escalation)
n=42 participants at risk
BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Candida infection
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
100.0%
3/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
40.0%
2/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
50.0%
2/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
50.0%
5/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
35.7%
15/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
11.9%
5/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
100.0%
1/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
30.0%
3/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
14.3%
6/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
11.9%
5/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Gastrointestinal disorders
Tongue discomfort
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Gastrointestinal disorders
Tooth demineralisation
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
100.0%
1/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
11.9%
5/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
General disorders
Asthenia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
7.1%
3/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
General disorders
Chills
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
2/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
100.0%
1/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
40.0%
2/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
14.3%
6/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
General disorders
Hyperthermia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
2/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
General disorders
Oedema
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
100.0%
1/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
9.5%
4/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
General disorders
Pain
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
100.0%
1/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
50.0%
2/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
66.7%
2/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
30.0%
3/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
26.2%
11/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
General disorders
Swelling
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
50.0%
2/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
70.0%
7/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
66.7%
2/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
28.6%
12/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Device related infection
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
100.0%
1/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
7.1%
3/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Influenza
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
7.1%
3/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
7.1%
3/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Otitis media
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
2/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
7.1%
3/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
2/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
9.5%
4/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
7.1%
3/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
2/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
7.1%
3/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
2/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
7.1%
3/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
9.5%
4/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
7.1%
3/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
2/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
14.3%
6/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Blood glucose increased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Blood immunoglobulin G decreased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
2/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
7.1%
3/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Blood immunoglobulin G increased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Blood urea increased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Blood uric acid decreased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
2/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
9.5%
4/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Eosinophil count decreased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
66.7%
2/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
9.5%
4/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
100.0%
1/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
50.0%
1/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
66.7%
2/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
66.7%
2/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
60.0%
3/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
50.0%
2/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
66.7%
2/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
50.0%
5/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
66.7%
2/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
54.8%
23/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Monocyte count decreased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
66.7%
2/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
50.0%
5/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
23.8%
10/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
50.0%
2/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
30.0%
3/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
66.7%
2/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
23.8%
10/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
100.0%
1/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
66.7%
2/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
60.0%
6/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
66.7%
2/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
38.1%
16/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Investigations
pH urine increased
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
66.7%
2/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
9.5%
4/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
50.0%
1/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
40.0%
4/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
66.7%
2/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
16.7%
7/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
7.1%
3/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
100.0%
1/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
2/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
14.3%
6/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
100.0%
1/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
7.1%
3/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
100.0%
1/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
40.0%
2/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
16.7%
7/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
2/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
30.0%
3/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
11.9%
5/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
2/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
100.0%
1/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
2/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
66.7%
2/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
60.0%
3/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
50.0%
5/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
66.7%
2/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
31.0%
13/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Nervous system disorders
Tongue paralysis
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
50.0%
1/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
30.0%
3/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
9.5%
4/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
7.1%
3/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
2/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
11.9%
5/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
100.0%
1/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
25.0%
1/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Vascular disorders
Haematoma
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
33.3%
1/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
4.8%
2/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
10.0%
1/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/2 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/1 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
20.0%
1/5 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/4 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/10 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
0.00%
0/3 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
2.4%
1/42 • Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Treated set (TS): all patients who were administered trial medication.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER