Trial Outcomes & Findings for A Phase 1/2a Study of Human Anti-CD 38 Antibody MOR03087 (MOR202) in Relapsed/Refractory Multiple Myeloma (NCT NCT01421186)
NCT ID: NCT01421186
Last Updated: 2021-11-16
Results Overview
1. as monotherapy 2. in combination with dexamethasone 3. in combination with pomalidomide + dexamethasone 4. in combination with lenalidomide + dexamethasone
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
91 participants
Primary outcome timeframe
First cycle of treatment
Results posted on
2021-11-16
Participant Flow
Participant milestones
| Measure |
Part A: MOR03087 Biweekly Dose Escalation
Treatment cycle 28 days, MOR03087 doses applied day 1 \& 15, initial 0.01 mg/kg, max 16 mg/kg
|
Part B: MOR03087 Weekly Dose Escalation
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
|
Part C: MOR03087 Plus Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old)
|
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
|
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old).
Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
4
|
18
|
21
|
17
|
|
Overall Study
COMPLETED
|
31
|
4
|
18
|
21
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 1/2a Study of Human Anti-CD 38 Antibody MOR03087 (MOR202) in Relapsed/Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Part A: MOR03087 Biweekly Dose Escalation
n=31 Participants
Treatment cycle 28 days, MOR03087 doses applied day 1 \& 15, initial 0.01 mg/kg, max 16 mg/kg
|
Part B: MOR03087 Weekly Dose Escalation
n=4 Participants
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
|
Part C: MOR03087 Plus Dexamethasone
n=18 Participants
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old)
|
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
n=21 Participants
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
|
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
n=17 Participants
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old).
Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
57 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
33 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
58 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
91 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
Austria
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
4 participants
n=10 Participants
|
|
Region of Enrollment
Germany
|
31 participants
n=5 Participants
|
4 participants
n=7 Participants
|
15 participants
n=5 Participants
|
20 participants
n=4 Participants
|
17 participants
n=21 Participants
|
87 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: First cycle of treatment1. as monotherapy 2. in combination with dexamethasone 3. in combination with pomalidomide + dexamethasone 4. in combination with lenalidomide + dexamethasone
Outcome measures
| Measure |
Part A: MOR03087 Biweekly Dose Escalation
n=31 Participants
Treatment cycle 28 days, MOR03087 doses applied day 1 \& 15, initial 0.01 mg/kg, max 16 mg/kg
|
Part B: MOR03087 Weekly Dose Escalation
n=4 Participants
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
|
Part C: MOR03087 Plus Dexamethasone
n=18 Participants
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old)
|
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
n=21 Participants
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
|
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
n=17 Participants
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old).
Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
|
|---|---|---|---|---|---|
|
Determination of Maximum Tolerated Dose and / or Recommended Dose and Dosing Regimen of MOR03087
|
16 mg/kg
|
16 mg/kg
|
16 mg/kg
|
16 mg/kg
|
16 mg/kg
|
PRIMARY outcome
Timeframe: during treatment period, maximum 3 years after 1st dosePopulation: all patients with available data
Number of participants who develop anti-MOR03087 antibodies, a measure of immunogenicity
Outcome measures
| Measure |
Part A: MOR03087 Biweekly Dose Escalation
n=31 Participants
Treatment cycle 28 days, MOR03087 doses applied day 1 \& 15, initial 0.01 mg/kg, max 16 mg/kg
|
Part B: MOR03087 Weekly Dose Escalation
n=4 Participants
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
|
Part C: MOR03087 Plus Dexamethasone
n=18 Participants
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old)
|
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
n=21 Participants
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
|
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
n=17 Participants
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old).
Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
|
|---|---|---|---|---|---|
|
Number of Participants Who Develop Anti-MOR03087 Antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: maximum 3 years after 1st dosenumber (#) of patients responding (# stringent complete response + # complete response + # very good partial response + # partial response)
Outcome measures
| Measure |
Part A: MOR03087 Biweekly Dose Escalation
n=31 Participants
Treatment cycle 28 days, MOR03087 doses applied day 1 \& 15, initial 0.01 mg/kg, max 16 mg/kg
|
Part B: MOR03087 Weekly Dose Escalation
n=4 Participants
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
|
Part C: MOR03087 Plus Dexamethasone
n=18 Participants
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old)
|
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
n=21 Participants
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
|
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
n=17 Participants
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old).
Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
|
|---|---|---|---|---|---|
|
Overall Response Rate
|
0 Participants
|
0 Participants
|
5 Participants
|
10 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: patients were observed for up to 36 monthsPopulation: safety population
Time to Progression (Kaplan Meier estimate)
Outcome measures
| Measure |
Part A: MOR03087 Biweekly Dose Escalation
n=31 Participants
Treatment cycle 28 days, MOR03087 doses applied day 1 \& 15, initial 0.01 mg/kg, max 16 mg/kg
|
Part B: MOR03087 Weekly Dose Escalation
n=4 Participants
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
|
Part C: MOR03087 Plus Dexamethasone
n=18 Participants
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old)
|
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
n=21 Participants
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
|
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
n=17 Participants
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old).
Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
|
|---|---|---|---|---|---|
|
Time to Progression
|
1.1 months
Interval 1.0 to 1.4
|
2.1 months
Interval 0.7 to
Upper confidence limit could not be estimated due to low number of patients with an event.
|
8.4 months
Interval 1.4 to 11.1
|
15.9 months
Interval 4.1 to 25.8
|
33.2 months
Interval 5.1 to
Upper confidence limit could not be estimated due to low number of patients with an event.
|
SECONDARY outcome
Timeframe: patients were observed up to 36 monthsProgression-free survival (Kaplan Meier estimates)
Outcome measures
| Measure |
Part A: MOR03087 Biweekly Dose Escalation
n=31 Participants
Treatment cycle 28 days, MOR03087 doses applied day 1 \& 15, initial 0.01 mg/kg, max 16 mg/kg
|
Part B: MOR03087 Weekly Dose Escalation
n=4 Participants
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
|
Part C: MOR03087 Plus Dexamethasone
n=18 Participants
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old)
|
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
n=21 Participants
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
|
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
n=17 Participants
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old).
Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
|
|---|---|---|---|---|---|
|
Progression-free Survival
|
1.1 months
Interval 1.0 to 1.4
|
2.1 months
Interval 0.7 to
Upper confidence limit could not be estimated due to low number of patients with an event.
|
8.4 months
Interval 1.4 to 11.1
|
15.9 months
Interval 3.0 to 22.1
|
26.7 months
Interval 5.1 to
Upper confidence limit could not be estimated due to low number of patients with an event.
|
SECONDARY outcome
Timeframe: patients were observed up to 36 monthsPopulation: Of the total 91 patients, 26 obtained a response: 5 in part C, 10 in part D and 11 in part E. Duration of response was calculated only in these patients.
Duration of response (Kaplan Meier estimates)
Outcome measures
| Measure |
Part A: MOR03087 Biweekly Dose Escalation
n=5 Participants
Treatment cycle 28 days, MOR03087 doses applied day 1 \& 15, initial 0.01 mg/kg, max 16 mg/kg
|
Part B: MOR03087 Weekly Dose Escalation
n=10 Participants
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
|
Part C: MOR03087 Plus Dexamethasone
n=11 Participants
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old)
|
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
|
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old).
Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
|
|---|---|---|---|---|---|
|
Duration of Response
|
16.7 months
Interval 1.9 to
Upper confidence limit could not be estimated due to low number of patients with an event.
|
21.2 months
Interval 9.2 to
Upper confidence limit could not be estimated due to low number of patients with an event.
|
32.2 months
Interval 4.2 to
Upper confidence limit could not be estimated due to low number of patients with an event.
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 7 days after last MOR202 dosePopulation: Pharmakokinetics was analysed on all available data on patients receiving 4mg/kg weekly, 8mg/kg weekly and 16 mg/kg weekly irrespective in which part the patients were treated.
PK analysis for MOR202 4, 8 and 16 mg/kg IV once weekly dose groups only, since serum concentrations of MOR202 were substantially affected by target mediated drug disposition effects for remaining dose groups
Outcome measures
| Measure |
Part A: MOR03087 Biweekly Dose Escalation
n=4 Participants
Treatment cycle 28 days, MOR03087 doses applied day 1 \& 15, initial 0.01 mg/kg, max 16 mg/kg
|
Part B: MOR03087 Weekly Dose Escalation
n=14 Participants
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
|
Part C: MOR03087 Plus Dexamethasone
n=39 Participants
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old)
|
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
|
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old).
Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Cmax - Maximum Observed Serum Concentration for MOR202
|
137.86 µg/mL
Standard Deviation 79.43
|
311.67 µg/mL
Standard Deviation 118.33
|
681.53 µg/mL
Standard Deviation 226.69
|
—
|
—
|
SECONDARY outcome
Timeframe: 56 daysPopulation: Pharmakokinetics was analysed on all available data on patients receiving 4mg/kg weekly, 8mg/kg weekly and 16 mg/kg weekly irrespective in which part the patients were treated.
PK analysis for MOR202 4, 8 and 16 mg/kg IV once weekly dose groups only, since serum concentrations of MOR202 were substantially affected by target mediated drug disposition effects for remaining dose groups
Outcome measures
| Measure |
Part A: MOR03087 Biweekly Dose Escalation
n=4 Participants
Treatment cycle 28 days, MOR03087 doses applied day 1 \& 15, initial 0.01 mg/kg, max 16 mg/kg
|
Part B: MOR03087 Weekly Dose Escalation
n=14 Participants
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
|
Part C: MOR03087 Plus Dexamethasone
n=39 Participants
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old)
|
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
|
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old).
Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
|
|---|---|---|---|---|---|
|
Pharmacokinetics: AUC Cycle 1+2 - Area Under the Time/Concentration Curve for MOR202
|
3307.57 mg*days/L
Standard Deviation 2332.07
|
7970.15 mg*days/L
Standard Deviation 4289.21
|
18178.57 mg*days/L
Standard Deviation 8414.44
|
—
|
—
|
Adverse Events
Part A: MOR03087 Biweekly Dose Escalation
Serious events: 13 serious events
Other events: 31 other events
Deaths: 2 deaths
Part B: MOR03087 Weekly Dose Escalation
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Part C: MOR03087 Plus Dexamethasone
Serious events: 7 serious events
Other events: 18 other events
Deaths: 0 deaths
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
Serious events: 20 serious events
Other events: 21 other events
Deaths: 1 deaths
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
Serious events: 14 serious events
Other events: 17 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Part A: MOR03087 Biweekly Dose Escalation
n=31 participants at risk
Treatment cycle 28 days, MOR03087 doses applied day 1 \& 15, initial 0.01 mg/kg, max 16 mg/kg
|
Part B: MOR03087 Weekly Dose Escalation
n=4 participants at risk
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg For all parts, patients will be treated until PD or until a maximum of 3 years after first treatment.
MOR03087: MOR03087 will be administered according to the Maximum Tolerated Dose (MTD) or recommended dose and dosing regimen for MOR03087 from parts A-E of the phase I dose escalation. The biweekly MOR03087 regimen as described in part A; the weekly regimen as described for parts B-E..
|
Part C: MOR03087 Plus Dexamethasone
n=18 participants at risk
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old)
|
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
n=21 participants at risk
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
|
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
n=17 participants at risk
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old).
Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
|
|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
28.6%
6/21 • Number of events 9 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
14.3%
3/21 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Bronchitis
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.1%
2/18 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Pulmonary Sepsis
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Skin Infection
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Injury, poisoning and procedural complications
Infusion-related reaction
|
12.9%
4/31 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
100.0%
4/4 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma Cell Myeloma
|
12.9%
4/31 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.5%
2/31 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
General disorders
Pyrexia
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Renal and urinary disorders
Acute Kidney Injury
|
6.5%
2/31 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Cardiac disorders
Cardiac Failure
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Cardiac disorders
Cardiovascular Disorder
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
General disorders
Cheast Pain
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of Jaw
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Renal and urinary disorders
Renal Failure
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Gastrointestinal disorders
Mouth Haemorrhage
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Infectious Pleural Effusion
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Erysipelas
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Influenza
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Meningoencephalitis Bacterial
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Parainfluenza Virus Infection
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Infection
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Sinusitis
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Respiratory Syncytal Virus Infection
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Varicella Zoster Virus Infection
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Injury, poisoning and procedural complications
Sternal Fracture
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eccrine Carcinoma
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of the Skin
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Vascular disorders
Thrombosis
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
Other adverse events
| Measure |
Part A: MOR03087 Biweekly Dose Escalation
n=31 participants at risk
Treatment cycle 28 days, MOR03087 doses applied day 1 \& 15, initial 0.01 mg/kg, max 16 mg/kg
|
Part B: MOR03087 Weekly Dose Escalation
n=4 participants at risk
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg For all parts, patients will be treated until PD or until a maximum of 3 years after first treatment.
MOR03087: MOR03087 will be administered according to the Maximum Tolerated Dose (MTD) or recommended dose and dosing regimen for MOR03087 from parts A-E of the phase I dose escalation. The biweekly MOR03087 regimen as described in part A; the weekly regimen as described for parts B-E..
|
Part C: MOR03087 Plus Dexamethasone
n=18 participants at risk
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old)
|
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
n=21 participants at risk
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
|
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
n=17 participants at risk
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 \& 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (\> 75 years old).
Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
|
|---|---|---|---|---|---|
|
General disorders
Fatigue
|
35.5%
11/31 • Number of events 12 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
33.3%
6/18 • Number of events 14 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
57.1%
12/21 • Number of events 22 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
35.3%
6/17 • Number of events 9 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Blood and lymphatic system disorders
Leukopenia
|
25.8%
8/31 • Number of events 13 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
100.0%
4/4 • Number of events 7 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
44.4%
8/18 • Number of events 28 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
81.0%
17/21 • Number of events 91 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
88.2%
15/17 • Number of events 55 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Nasopharyngitis
|
19.4%
6/31 • Number of events 8 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
50.0%
9/18 • Number of events 12 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
19.0%
4/21 • Number of events 12 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
35.3%
6/17 • Number of events 10 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.9%
4/31 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
75.0%
3/4 • Number of events 12 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
44.4%
8/18 • Number of events 26 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
90.5%
19/21 • Number of events 113 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
70.6%
12/17 • Number of events 49 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.1%
5/31 • Number of events 9 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
50.0%
2/4 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
44.4%
8/18 • Number of events 25 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
66.7%
14/21 • Number of events 43 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
76.5%
13/17 • Number of events 33 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Blood and lymphatic system disorders
Anaemia
|
41.9%
13/31 • Number of events 20 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
38.9%
7/18 • Number of events 10 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
52.4%
11/21 • Number of events 34 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
35.3%
6/17 • Number of events 16 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.7%
3/31 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
33.3%
6/18 • Number of events 9 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
66.7%
14/21 • Number of events 51 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
64.7%
11/17 • Number of events 24 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Investigations
C-reactive proteine increased
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
16.7%
3/18 • Number of events 8 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
14.3%
3/21 • Number of events 10 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
17.6%
3/17 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
19.0%
4/21 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
23.5%
4/17 • Number of events 6 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Investigations
Blood lactate dehydrogenase increased
|
9.7%
3/31 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
23.5%
4/17 • Number of events 6 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Investigations
Lipase increased
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
16.7%
3/18 • Number of events 14 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
17.6%
3/17 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Investigations
Amylase increased
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.1%
2/18 • Number of events 5 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
14.3%
3/21 • Number of events 5 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Investigations
Blood creatinine phosphokinase increased
|
6.5%
2/31 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Investigations
Blood creatinine increased
|
6.5%
2/31 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.1%
2/18 • Number of events 10 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Upper respiratory tract infection
|
9.7%
3/31 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
33.3%
6/18 • Number of events 7 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
23.8%
5/21 • Number of events 10 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
35.3%
6/17 • Number of events 10 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Respiratory tract infection
|
6.5%
2/31 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.1%
2/18 • Number of events 12 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
38.1%
8/21 • Number of events 18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
23.5%
4/17 • Number of events 8 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Pneumonia
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
19.0%
4/21 • Number of events 5 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.8%
2/17 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Bronchitis
|
12.9%
4/31 • Number of events 5 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.1%
2/18 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Urinary tract infection
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
16.7%
3/18 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.8%
2/17 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Infection
|
6.5%
2/31 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
19.0%
4/21 • Number of events 6 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Rhinitis
|
6.5%
2/31 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
14.3%
3/21 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Oral herpes
|
3.2%
1/31 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.1%
2/18 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
General disorders
Pyrexia
|
16.1%
5/31 • Number of events 6 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
16.7%
3/18 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
23.8%
5/21 • Number of events 7 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.8%
2/17 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
General disorders
Disease progression
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.1%
2/18 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
23.8%
5/21 • Number of events 5 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
17.6%
3/17 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
General disorders
Oedema peripheral
|
9.7%
3/31 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.1%
2/18 • Number of events 8 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
23.5%
4/17 • Number of events 5 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
General disorders
Asthenia
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
16.7%
3/18 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Gastrointestinal disorders
Diarrhea
|
22.6%
7/31 • Number of events 9 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
22.2%
4/18 • Number of events 5 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
52.4%
11/21 • Number of events 15 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
58.8%
10/17 • Number of events 26 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Gastrointestinal disorders
Constipation
|
12.9%
4/31 • Number of events 5 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
23.8%
5/21 • Number of events 8 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
64.7%
11/17 • Number of events 13 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.1%
2/18 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
17.6%
3/17 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Gastrointestinal disorders
Nausea
|
32.3%
10/31 • Number of events 14 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.1%
2/18 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 10 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
35.3%
6/17 • Number of events 8 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
14.3%
3/21 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
23.5%
4/17 • Number of events 5 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Gastrointestinal disorders
Vomiting
|
12.9%
4/31 • Number of events 6 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 7 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
19.0%
4/21 • Number of events 5 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Gastrointestinal disorders
Dry mouth
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.8%
2/17 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
51.6%
16/31 • Number of events 16 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
50.0%
2/4 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
66.7%
12/18 • Number of events 12 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
42.9%
9/21 • Number of events 9 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
17.6%
3/17 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.1%
5/31 • Number of events 7 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.1%
2/18 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
28.6%
6/21 • Number of events 11 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
35.3%
6/17 • Number of events 7 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
17.6%
3/17 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
29.4%
5/17 • Number of events 5 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
9.7%
3/31 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.8%
2/17 • Number of events 7 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.1%
2/18 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
14.3%
3/21 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.8%
2/17 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.1%
2/18 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.8%
2/17 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.5%
2/31 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.1%
2/18 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
9.7%
3/31 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.1%
2/18 • Number of events 5 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
23.8%
5/21 • Number of events 9 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
52.9%
9/17 • Number of events 12 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
33.3%
6/18 • Number of events 7 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
33.3%
7/21 • Number of events 9 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
17.6%
3/17 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
2/31 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
16.7%
3/18 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
19.0%
4/21 • Number of events 6 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.8%
2/17 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.7%
3/31 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
22.2%
4/18 • Number of events 5 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.8%
2/17 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.7%
3/31 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
19.0%
4/21 • Number of events 5 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
16.1%
5/31 • Number of events 5 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
17.6%
3/17 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
19.4%
6/31 • Number of events 8 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
16.7%
3/18 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.7%
3/31 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
50.0%
2/4 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
16.7%
3/18 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
23.8%
5/21 • Number of events 8 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
29.4%
5/17 • Number of events 6 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.9%
4/31 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
16.7%
3/18 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
17.6%
3/17 • Number of events 8 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Nervous system disorders
Headache
|
19.4%
6/31 • Number of events 8 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
33.3%
6/18 • Number of events 8 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Nervous system disorders
Dizziness
|
9.7%
3/31 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
16.7%
3/18 • Number of events 5 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
29.4%
5/17 • Number of events 6 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Nervous system disorders
Paraesthesia
|
6.5%
2/31 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
19.0%
4/21 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.1%
2/18 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
23.8%
5/21 • Number of events 13 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
29.4%
5/17 • Number of events 6 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.5%
2/31 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
14.3%
3/21 • Number of events 5 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.8%
2/17 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
9.7%
3/31 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
17.6%
3/17 • Number of events 6 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.7%
3/31 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
14.3%
3/21 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
16.7%
3/18 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Vascular disorders
Hypertension
|
12.9%
4/31 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
16.7%
3/18 • Number of events 9 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
23.8%
5/21 • Number of events 5 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.8%
2/17 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Vascular disorders
Haematoma
|
6.5%
2/31 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
16.7%
3/18 • Number of events 9 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
14.3%
3/21 • Number of events 6 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
17.6%
3/17 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Vascular disorders
Hypotension
|
9.7%
3/31 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.1%
2/18 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
17.6%
3/17 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Psychiatric disorders
Insomnia
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
33.3%
6/18 • Number of events 21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Cardiac disorders
Tachycardia
|
9.7%
3/31 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
50.0%
2/4 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
16.7%
3/18 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Eye disorders
Cataract
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
17.6%
3/17 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
14.3%
3/21 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Ear and labyrinth disorders
Vertigo
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
23.5%
4/17 • Number of events 6 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Blood and lymphatic system disorders
Blood urea increased
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.8%
2/17 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Blood and lymphatic system disorders
Neutrophilia
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
General disorders
Pain
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
General disorders
Swelling
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.1%
2/18 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
General disorders
Impaired healing
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
6.5%
2/31 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
16.7%
3/18 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.1%
2/18 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.5%
2/31 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.5%
2/31 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.5%
2/31 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Nervous system disorders
Dysaesthesia
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Nervous system disorders
Polyneuropathy
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Nervous system disorders
Somnolence
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Skin and subcutaneous tissue disorders
Nail growth abnormal
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Vascular disorders
Hot flush
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Vascular disorders
Iliac artery stenosis
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Vascular disorders
Varicous vein
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Vascular disorders
Restlessness
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
14.3%
3/21 • Number of events 3 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Psychiatric disorders
Confusional state
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Psychiatric disorders
Agitation
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
9.5%
2/21 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Eye disorders
Vision blurred
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Eye disorders
Visual impairment
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Eye disorders
Diplopia
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Cardiac disorders
Angina pectoris
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Cardiac disorders
Palpitations
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
25.0%
1/4 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
11.8%
2/17 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Renal and urinary disorders
Renal failure
|
3.2%
1/31 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.6%
1/18 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/21 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/17 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/31 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/4 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
0.00%
0/18 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
4.8%
1/21 • Number of events 2 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
5.9%
1/17 • Number of events 1 • during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
regular investigator assessment and laboratory testing
|
Additional Information
Dr Winrich Rauschning, Clinical Project Lead (external)
MorphoSys AG
Phone: +4989 89927
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place