Trial Outcomes & Findings for Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer (NCT NCT01666314)
NCT ID: NCT01666314
Last Updated: 2018-03-20
Results Overview
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
137 participants
Primary outcome timeframe
Baseline and Week 4
Results posted on
2018-03-20
Participant Flow
Participants took part in the study at 43 investigative sites in Japan, United States, Greece, Australia, Netherlands, Ireland and United Kingdom from 20 August 2012 to 01 September 2016.
Male participants with a diagnosis of adenocarcinoma of the prostate were enrolled in the study. In Japan, participants were randomized to 200 mg orteronel, Placebo, 300 mg orteronel, or Placebo, BID, in a ratio of 2:1:2:1; ex-Japan participants were randomized to 200 mg orteronel, Placebo, 400 mg orteronel, or Placebo, BID, in a ratio of 2:1:2:1.
Participant milestones
| Measure |
Placebo + Orteronel 200 mg (Japan)
Orteronel placebo-matching tablets or Orteronel 200 mg, tablets, orally, twice daily (BID) in Cycle 1 (28 days) followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily continuously throughout the study.
|
Placebo + Orteronel 300 mg (Japan)
Orteronel placebo-matching tablets or Orteronel 300 mg, tablets, orally, twice daily in Cycle 1 followed by orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo + Orteronel 200 mg (Ex-Japan)
Orteronel placebo-matching tablets, or Orteronel 200 mg, tablets, orally, twice daily in Cycle 1 followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles outside of Japan (Ex-Japan) for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo + Orteronel 400 mg (Ex-Japan)
Orteronel placebo-matching tablets, or Orteronel 400 mg, tablets, orally, twice daily in Cycle 1 followed by orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
32
|
36
|
36
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
33
|
32
|
36
|
36
|
Reasons for withdrawal
| Measure |
Placebo + Orteronel 200 mg (Japan)
Orteronel placebo-matching tablets or Orteronel 200 mg, tablets, orally, twice daily (BID) in Cycle 1 (28 days) followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily continuously throughout the study.
|
Placebo + Orteronel 300 mg (Japan)
Orteronel placebo-matching tablets or Orteronel 300 mg, tablets, orally, twice daily in Cycle 1 followed by orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo + Orteronel 200 mg (Ex-Japan)
Orteronel placebo-matching tablets, or Orteronel 200 mg, tablets, orally, twice daily in Cycle 1 followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles outside of Japan (Ex-Japan) for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo + Orteronel 400 mg (Ex-Japan)
Orteronel placebo-matching tablets, or Orteronel 400 mg, tablets, orally, twice daily in Cycle 1 followed by orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
13
|
7
|
7
|
|
Overall Study
Progressive Disease
|
11
|
9
|
19
|
20
|
|
Overall Study
Symptomatic Deterioration
|
1
|
0
|
2
|
0
|
|
Overall Study
Unsatisfactory Therapeutic Response
|
7
|
2
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
3
|
|
Overall Study
Reason not Specified
|
10
|
7
|
5
|
5
|
Baseline Characteristics
Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Placebo + Orteronel 200 mg (Japan)
n=11 Participants
Orteronel placebo-matching tablets, orally, twice daily (BID) in Cycle 1 (28 days) followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily continuously throughout the study.
|
Orteronel 200 mg (Japan)
n=22 Participants
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo + Orteronel 300 mg (Japan)
n=10 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo + Orteronel 200 mg (Ex-Japan)
n=11 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles outside of Japan (Ex-Japan) for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
n=25 Participants
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo + Orteronel 400 mg (Ex-Japan)
n=12 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
n=24 Participants
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
72.1 years
n=5 Participants
|
68.5 years
n=7 Participants
|
70.1 years
n=5 Participants
|
71.5 years
n=4 Participants
|
69.6 years
n=21 Participants
|
69.9 years
n=10 Participants
|
73.3 years
n=115 Participants
|
69.4 years
n=24 Participants
|
70.6 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
24 Participants
n=24 Participants
|
137 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
23 Participants
n=24 Participants
|
136 Participants
n=42 Participants
|
|
Ethnicity (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
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
11 participants
n=21 Participants
|
25 participants
n=10 Participants
|
11 participants
n=115 Participants
|
23 participants
n=24 Participants
|
70 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
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
|
1 participants
n=115 Participants
|
1 participants
n=24 Participants
|
2 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese
|
11 participants
n=5 Participants
|
22 participants
n=7 Participants
|
10 participants
n=5 Participants
|
22 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=24 Participants
|
65 participants
n=42 Participants
|
|
Region of Enrollment
Japan
|
11 participants
n=5 Participants
|
22 participants
n=7 Participants
|
10 participants
n=5 Participants
|
22 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
0 participants
n=24 Participants
|
65 participants
n=42 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
1 participants
n=10 Participants
|
2 participants
n=115 Participants
|
2 participants
n=24 Participants
|
8 participants
n=42 Participants
|
|
Region of Enrollment
Greece
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
4 participants
n=10 Participants
|
1 participants
n=115 Participants
|
3 participants
n=24 Participants
|
10 participants
n=42 Participants
|
|
Region of Enrollment
Ireland
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
5 participants
n=10 Participants
|
3 participants
n=115 Participants
|
3 participants
n=24 Participants
|
13 participants
n=42 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
6 participants
n=10 Participants
|
1 participants
n=115 Participants
|
5 participants
n=24 Participants
|
13 participants
n=42 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
1 participants
n=24 Participants
|
3 participants
n=42 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
9 participants
n=10 Participants
|
4 participants
n=115 Participants
|
10 participants
n=24 Participants
|
25 participants
n=42 Participants
|
|
Height
|
161.94 cm
n=5 Participants
|
167.10 cm
n=7 Participants
|
163.92 cm
n=5 Participants
|
164.71 cm
n=4 Participants
|
170.41 cm
n=21 Participants
|
174.79 cm
n=10 Participants
|
176.70 cm
n=115 Participants
|
174.74 cm
n=24 Participants
|
169.29 cm
n=42 Participants
|
|
Weight
|
65.82 kg
n=5 Participants
|
70.32 kg
n=7 Participants
|
65.75 kg
n=5 Participants
|
64.49 kg
n=4 Participants
|
87.34 kg
n=21 Participants
|
90.39 kg
n=10 Participants
|
88.23 kg
n=115 Participants
|
89.85 kg
n=24 Participants
|
77.77 kg
n=42 Participants
|
|
Body Mass Index (BMI)
|
25.05 kg/m^2
n=5 Participants
|
25.21 kg/m^2
n=7 Participants
|
24.43 kg/m^2
n=5 Participants
|
23.73 kg/m^2
n=4 Participants
|
29.85 kg/m^2
n=21 Participants
|
29.61 kg/m^2
n=10 Participants
|
28.37 kg/m^2
n=115 Participants
|
29.40 kg/m^2
n=24 Participants
|
26.96 kg/m^2
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Outcome measures
| Measure |
Placebo (Japan)
n=21 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan
|
86.0 percentage of participants
Interval 63.7 to 97.0
|
100.0 percentage of participants
Interval 84.6 to 100.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Outcome measures
| Measure |
Placebo (Japan)
n=23 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=24 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan
|
48.0 percentage of participants
Interval 26.8 to 69.4
|
79.0 percentage of participants
Interval 57.8 to 92.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 4 Weeks of Treatment.
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Outcome measures
| Measure |
Placebo (Japan)
n=21 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
n=20 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
n=21 Participants
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
n=22 Participants
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment
|
-87.666 percent change
Standard Deviation 10.4250
|
-97.245 percent change
Standard Deviation 1.2548
|
-96.812 percent change
Standard Deviation 2.7055
|
-63.702 percent change
Standard Deviation 43.3941
|
-86.268 percent change
Standard Deviation 37.2015
|
-53.954 percent change
Standard Deviation 118.8050
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 12 Weeks of Treatment.
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Outcome measures
| Measure |
Placebo (Japan)
n=31 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=26 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=28 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
n=31 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment
|
-95.804 percent change
Standard Deviation 5.3367
|
-95.703 percent change
Standard Deviation 5.7468
|
-91.311 percent change
Standard Deviation 17.5217
|
-14.442 percent change
Standard Deviation 406.3116
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 4 Weeks of Treatment.
A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.
Outcome measures
| Measure |
Placebo (Japan)
n=21 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
n=23 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
n=25 Participants
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
n=24 Participants
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment
|
48.0 percentage of participants
Interval 25.7 to 70.2
|
50.0 percentage of participants
Interval 28.2 to 71.8
|
41.0 percentage of participants
Interval 20.7 to 63.6
|
17.0 percentage of participants
Interval 5.0 to 38.8
|
48.0 percentage of participants
Interval 27.8 to 68.7
|
46.0 percentage of participants
Interval 25.6 to 67.2
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 12 Weeks of Treatment.
A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.
Outcome measures
| Measure |
Placebo (Japan)
n=33 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=32 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=36 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
n=36 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With PSA50 After 12 Weeks of Treatment
|
55.0 percentage of participants
Interval 36.4 to 71.9
|
47.0 percentage of participants
Interval 29.1 to 65.3
|
56.0 percentage of participants
Interval 38.1 to 72.1
|
44.0 percentage of participants
Interval 27.9 to 61.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1Population: Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.
Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
Outcome measures
| Measure |
Placebo (Japan)
n=21 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
n=23 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
n=25 Participants
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
n=24 Participants
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
Absolute Values for Testosterone
Baseline
|
9.749 ng/dL
Standard Deviation 3.8460
|
9.079 ng/dL
Standard Deviation 4.4581
|
10.148 ng/dL
Standard Deviation 4.6504
|
9.173 ng/dL
Standard Deviation 5.6123
|
9.263 ng/dL
Standard Deviation 5.6572
|
14.588 ng/dL
Standard Deviation 13.9833
|
|
Absolute Values for Testosterone
Cycle 1 Day 8
|
1.957 ng/dL
Standard Deviation 2.2843
|
0.213 ng/dL
Standard Deviation 0.0449
|
0.251 ng/dL
Standard Deviation 0.1727
|
3.509 ng/dL
Standard Deviation 4.3471
|
0.345 ng/dL
Standard Deviation 0.2770
|
6.658 ng/dL
Standard Deviation 20.4347
|
|
Absolute Values for Testosterone
Cycle 2 Day 1
|
1.096 ng/dL
Standard Deviation 0.7751
|
0.203 ng/dL
Standard Deviation 0.0145
|
0.270 ng/dL
Standard Deviation 0.2311
|
3.095 ng/dL
Standard Deviation 3.7254
|
0.266 ng/dL
Standard Deviation 0.1837
|
11.720 ng/dL
Standard Deviation 45.1753
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1Population: Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.
Serum Ultra low level quantification of DHEA-S was measured by liquid chromatography and mass spectrometry (LC/MS) at a central laboratory.
Outcome measures
| Measure |
Placebo (Japan)
n=21 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
n=23 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
n=25 Participants
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
n=24 Participants
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S)
Baseline
|
1928.0 nmol/L
Standard Deviation 1306.59
|
2529.0 nmol/L
Standard Deviation 1309.39
|
2340.9 nmol/L
Standard Deviation 1606.36
|
2601.7 nmol/L
Standard Deviation 3009.41
|
1783.0 nmol/L
Standard Deviation 1554.76
|
2155.7 nmol/L
Standard Deviation 1591.51
|
|
Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S)
Cycle 1 Day 8
|
414.9 nmol/L
Standard Deviation 392.63
|
63.4 nmol/L
Standard Deviation 55.11
|
71.8 nmol/L
Standard Deviation 80.23
|
973.8 nmol/L
Standard Deviation 1677.95
|
116.9 nmol/L
Standard Deviation 161.01
|
226.6 nmol/L
Standard Deviation 328.70
|
|
Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S)
Cycle 2 Day 1
|
268.9 nmol/L
Standard Deviation 357.32
|
14.5 nmol/L
Standard Deviation 21.83
|
36.3 nmol/L
Standard Deviation 123.48
|
815.7 nmol/L
Standard Deviation 1918.88
|
21.5 nmol/L
Standard Deviation 25.68
|
180.6 nmol/L
Standard Deviation 527.03
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1Population: Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.
Serum ACTH was measured by immunometric assay at the central laboratory.
Outcome measures
| Measure |
Placebo (Japan)
n=21 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
n=23 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
n=25 Participants
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
n=24 Participants
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
Absolute Values for Adrenocorticotropic Hormone (ACTH)
Baseline
|
5.0 pmol/L
Standard Deviation 1.66
|
5.5 pmol/L
Standard Deviation 2.54
|
8.3 pmol/L
Standard Deviation 4.98
|
4.7 pmol/L
Standard Deviation 2.06
|
6.0 pmol/L
Standard Deviation 4.05
|
6.4 pmol/L
Standard Deviation 4.04
|
|
Absolute Values for Adrenocorticotropic Hormone (ACTH)
Cycle 1 Day 8
|
3.1 pmol/L
Standard Deviation 2.68
|
2.3 pmol/L
Standard Deviation 1.55
|
3.0 pmol/L
Standard Deviation 2.70
|
3.1 pmol/L
Standard Deviation 2.62
|
3.8 pmol/L
Standard Deviation 3.04
|
3.2 pmol/L
Standard Deviation 2.56
|
|
Absolute Values for Adrenocorticotropic Hormone (ACTH)
Cycle 2 Day 1
|
1.7 pmol/L
Standard Deviation 1.19
|
1.7 pmol/L
Standard Deviation 1.08
|
2.7 pmol/L
Standard Deviation 2.17
|
3.0 pmol/L
Standard Deviation 1.73
|
3.7 pmol/L
Standard Deviation 4.38
|
3.6 pmol/L
Standard Deviation 2.26
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1Population: Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.
Serum Corticosterone was measured by high pressure liquid chromatography with mass spectrometry at the central laboratory.
Outcome measures
| Measure |
Placebo (Japan)
n=21 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
n=23 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
n=25 Participants
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
n=24 Participants
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
Absolute Values for Corticosterone
Baseline
|
5.946 nmol/L
Standard Deviation 3.4433
|
6.515 nmol/L
Standard Deviation 4.8246
|
7.768 nmol/L
Standard Deviation 6.8625
|
6.317 nmol/L
Standard Deviation 4.1467
|
10.030 nmol/L
Standard Deviation 7.7341
|
17.975 nmol/L
Standard Deviation 35.0695
|
|
Absolute Values for Corticosterone
Cycle 1 Day 8
|
1.530 nmol/L
Standard Deviation 1.6404
|
11.067 nmol/L
Standard Deviation 14.4220
|
9.709 nmol/L
Standard Deviation 13.4538
|
5.598 nmol/L
Standard Deviation 7.1366
|
48.668 nmol/L
Standard Deviation 66.3904
|
60.301 nmol/L
Standard Deviation 77.5434
|
|
Absolute Values for Corticosterone
Cycle 2 Day 1
|
0.758 nmol/L
Standard Deviation 0.5108
|
11.108 nmol/L
Standard Deviation 9.0708
|
14.654 nmol/L
Standard Deviation 9.2064
|
4.321 nmol/L
Standard Deviation 6.4063
|
29.929 nmol/L
Standard Deviation 35.5565
|
47.204 nmol/L
Standard Deviation 53.4566
|
SECONDARY outcome
Timeframe: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1Population: Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.
Serum Cortisol was measured by immunometric assay at the central laboratory.
Outcome measures
| Measure |
Placebo (Japan)
n=21 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
n=23 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
n=25 Participants
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
n=24 Participants
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
Absolute Values for Cortisol
Baseline
|
366.5 nmol/L
Standard Deviation 116.69
|
371.3 nmol/L
Standard Deviation 119.38
|
383.4 nmol/L
Standard Deviation 125.98
|
384.8 nmol/L
Standard Deviation 117.14
|
449.0 nmol/L
Standard Deviation 131.54
|
446.8 nmol/L
Standard Deviation 193.09
|
|
Absolute Values for Cortisol
Cycle 1 Day 8
|
82.3 nmol/L
Standard Deviation 46.16
|
49.5 nmol/L
Standard Deviation 25.53
|
55.5 nmol/L
Standard Deviation 55.97
|
175.8 nmol/L
Standard Deviation 107.82
|
100.9 nmol/L
Standard Deviation 87.38
|
122.0 nmol/L
Standard Deviation 88.70
|
|
Absolute Values for Cortisol
Cycle 2 Day 1
|
53.9 nmol/L
Standard Deviation 24.92
|
49.2 nmol/L
Standard Deviation 21.71
|
54.3 nmol/L
Standard Deviation 39.93
|
149.6 nmol/L
Standard Deviation 122.91
|
97.2 nmol/L
Standard Deviation 85.66
|
109.1 nmol/L
Standard Deviation 83.19
|
SECONDARY outcome
Timeframe: Baseline and Cycle 2 Day 1Population: Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.
Serum PSA was measured at the central laboratory.
Outcome measures
| Measure |
Placebo (Japan)
n=21 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
n=23 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
n=25 Participants
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
n=24 Participants
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
Absolute Values for Prostate-Specific Antigen (PSA)
Baseline
|
37.588 ng/mL
Standard Deviation 48.9413
|
27.227 ng/mL
Standard Deviation 24.8821
|
97.504 ng/mL
Standard Deviation 293.9496
|
133.238 ng/mL
Standard Deviation 189.9345
|
165.992 ng/mL
Standard Deviation 368.5016
|
100.237 ng/mL
Standard Deviation 210.5675
|
|
Absolute Values for Prostate-Specific Antigen (PSA)
Cycle 2 Day 1
|
24.325 ng/mL
Standard Deviation 46.9725
|
18.005 ng/mL
Standard Deviation 16.9858
|
38.892 ng/mL
Standard Deviation 95.0124
|
152.940 ng/mL
Standard Deviation 261.9735
|
117.257 ng/mL
Standard Deviation 286.1870
|
56.437 ng/mL
Standard Deviation 97.1621
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dosePopulation: Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Outcome measures
| Measure |
Placebo (Japan)
n=22 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=25 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
n=24 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite
Orteronel
|
1520 ng/mL
Geometric Coefficient of Variation 23.9
|
2210 ng/mL
Geometric Coefficient of Variation 33.9
|
1300 ng/mL
Geometric Coefficient of Variation 59.7
|
1610 ng/mL
Geometric Coefficient of Variation 50.3
|
—
|
—
|
|
Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite
Orteronel Metabolite M-I
|
272 ng/mL
Geometric Coefficient of Variation 33.1
|
422 ng/mL
Geometric Coefficient of Variation 37.0
|
199 ng/mL
Geometric Coefficient of Variation 61.9
|
261 ng/mL
Geometric Coefficient of Variation 47.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dosePopulation: Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.
AUC(0-12) is measure of area under the curve over the dosing interval where the length of the dosing interval is time 0 to 12 hours in this study.
Outcome measures
| Measure |
Placebo (Japan)
n=22 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=25 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
n=24 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
AUC(0-12): Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours Post-dose for Orteronel and M-I Metabolite
Orteronel
|
8810 h*ng/mL
Geometric Coefficient of Variation 16.4
|
12800 h*ng/mL
Geometric Coefficient of Variation 31.2
|
7830 h*ng/mL
Geometric Coefficient of Variation 51.1
|
10200 h*ng/mL
Geometric Coefficient of Variation 41.4
|
—
|
—
|
|
AUC(0-12): Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours Post-dose for Orteronel and M-I Metabolite
Orteronel Metabolite M-I
|
2130 h*ng/mL
Geometric Coefficient of Variation 28.3
|
3290 h*ng/mL
Geometric Coefficient of Variation 33.8
|
1570 h*ng/mL
Geometric Coefficient of Variation 65.5
|
2080 h*ng/mL
Geometric Coefficient of Variation 44.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dosePopulation: Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Outcome measures
| Measure |
Placebo (Japan)
n=22 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=25 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
n=24 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite
Orteronel
|
2.97 hours
Interval 1.0 to 5.1
|
2.43 hours
Interval 1.0 to 4.97
|
2.00 hours
Interval 0.5 to 7.93
|
1.92 hours
Interval 0.5 to 5.0
|
—
|
—
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite
Orteronel Metabolite M-I
|
5.00 hours
Interval 2.03 to 8.1
|
4.98 hours
Interval 2.0 to 8.23
|
5.05 hours
Interval 1.03 to 11.1
|
4.98 hours
Interval 1.22 to 11.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dosePopulation: Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.
Cumulative amount of urine excreted time 0 to 24 hour.
Outcome measures
| Measure |
Placebo (Japan)
n=22 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=25 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
n=24 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
AE (0-24) Cumulative Amount of Drug Excreted Into the Urine for Orteronel and MI-Metabolite
Orteronel
|
115.0 mg
Geometric Coefficient of Variation 26.0
|
164.0 mg
Geometric Coefficient of Variation 26.2
|
95.3 mg
Geometric Coefficient of Variation 31.9
|
161.0 mg
Geometric Coefficient of Variation 41.4
|
—
|
—
|
|
AE (0-24) Cumulative Amount of Drug Excreted Into the Urine for Orteronel and MI-Metabolite
Orteronel Metabolite M-I
|
39.6 mg
Geometric Coefficient of Variation 31.5
|
62.5 mg
Geometric Coefficient of Variation 26.6
|
30.0 mg
Geometric Coefficient of Variation 40.1
|
52.8 mg
Geometric Coefficient of Variation 46.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dosePopulation: Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.
Maximum observed steady-state plasma concentration during a dosing interval.
Outcome measures
| Measure |
Placebo (Japan)
n=22 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=25 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
n=24 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
Cmax,ss: Maximum Observed Plasma Concentration at Steady State for Orteronel and MI-Metabolite
Orteronel
|
2180 ng/mL
Geometric Coefficient of Variation 22.4
|
3210 ng/mL
Geometric Coefficient of Variation 31.5
|
1840 ng/mL
Geometric Coefficient of Variation 37.1
|
3100 ng/mL
Geometric Coefficient of Variation 45.0
|
—
|
—
|
|
Cmax,ss: Maximum Observed Plasma Concentration at Steady State for Orteronel and MI-Metabolite
Orteronel Metabolite M-I
|
565 ng/mL
Geometric Coefficient of Variation 32.4
|
864 ng/mL
Geometric Coefficient of Variation 39.5
|
485 ng/mL
Geometric Coefficient of Variation 75.4
|
761 ng/mL
Geometric Coefficient of Variation 81.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dosePopulation: Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.
Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax at steady state.
Outcome measures
| Measure |
Placebo (Japan)
n=22 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=25 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
n=24 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax), Equal to Time (Hours) to Cmax at Steady State for Orteronel and M-I Metabolite
Orteronel
|
2.05 hours
Interval 1.0 to 5.08
|
2.96 hours
Interval 1.0 to 5.17
|
2.00 hours
Interval 0.55 to 5.17
|
1.98 hours
Interval 0.5 to 3.08
|
—
|
—
|
|
Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax), Equal to Time (Hours) to Cmax at Steady State for Orteronel and M-I Metabolite
Orteronel Metabolite M-I
|
3.08 hours
Interval 2.0 to 5.17
|
4.78 hours
Interval 2.0 to 8.13
|
3.00 hours
Interval 1.0 to 5.07
|
3.00 hours
Interval 0.0 to 8.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dosePopulation: Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.
Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.
Outcome measures
| Measure |
Placebo (Japan)
n=22 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=25 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
n=24 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Orteronel and M-I Metabolite
Orteronel
|
13300 h*ng/mL
Geometric Coefficient of Variation 20.4
|
20400 h*ng/mL
Geometric Coefficient of Variation 36.1
|
12600 h*ng/mL
Geometric Coefficient of Variation 36.2
|
20000 h*ng/mL
Geometric Coefficient of Variation 55.0
|
—
|
—
|
|
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Orteronel and M-I Metabolite
Orteronel Metabolite M-I
|
4840 h*ng/mL
Geometric Coefficient of Variation 35.0
|
7460 h*ng/mL
Geometric Coefficient of Variation 46.3
|
4340 h*ng/mL
Geometric Coefficient of Variation 69.4
|
6590 h*ng/mL
Geometric Coefficient of Variation 78.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dosePopulation: Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.
Rac was calculated as the ratio of AUCtau to AUC12hr.
Outcome measures
| Measure |
Placebo (Japan)
n=22 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=25 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
n=24 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
Rac: Accumulation Index for Orteronel and M-I Metabolite
Orteronel
|
1.51 ratio
Geometric Coefficient of Variation 9.1
|
1.59 ratio
Geometric Coefficient of Variation 46.6
|
1.62 ratio
Geometric Coefficient of Variation 39.3
|
1.97 ratio
Geometric Coefficient of Variation 90.5
|
—
|
—
|
|
Rac: Accumulation Index for Orteronel and M-I Metabolite
Orteronel Metabolite M-I
|
2.27 ratio
Geometric Coefficient of Variation 17.5
|
2.26 ratio
Geometric Coefficient of Variation 43.0
|
2.76 ratio
Geometric Coefficient of Variation 45.0
|
3.17 ratio
Geometric Coefficient of Variation 77.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8 PredosePopulation: Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.
Observed predose plasma concentration at steady state.
Outcome measures
| Measure |
Placebo (Japan)
n=22 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=22 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=24 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
n=22 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
Ctrough,ss: Observed Predose Plasma Concentration at Steady State for Orteronel and M-I Metabolite
Orteronel
|
710 ng/mL
Geometric Coefficient of Variation 28.1
|
1060 ng/mL
Geometric Coefficient of Variation 63.7
|
807 ng/mL
Geometric Coefficient of Variation 45.4
|
899 ng/mL
Geometric Coefficient of Variation 59.8
|
—
|
—
|
|
Ctrough,ss: Observed Predose Plasma Concentration at Steady State for Orteronel and M-I Metabolite
Orteronel Metbolite M-I
|
291 ng/mL
Geometric Coefficient of Variation 47.1
|
444 ng/mL
Geometric Coefficient of Variation 66.7
|
314 ng/mL
Geometric Coefficient of Variation 68.6
|
417 ng/mL
Geometric Coefficient of Variation 58.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 yearsPopulation: Safety Population included all randomized participants who received at least one dose of study drug. Adverse events are summarized as per the treatment received.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding),symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Outcome measures
| Measure |
Placebo (Japan)
n=21 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=33 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=32 Participants
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Placebo (Ex-Japan)
n=23 Participants
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
n=36 Participants
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400 mg (Ex-Japan)
n=36 Participants
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE
|
7 participants
|
33 participants
|
32 participants
|
18 participants
|
36 participants
|
36 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAE
|
0 participants
|
8 participants
|
18 participants
|
1 participants
|
16 participants
|
12 participants
|
Adverse Events
Placebo
Serious events: 10 serious events
Other events: 44 other events
Deaths: 0 deaths
Orteronel 200 mg (Japan)
Serious events: 8 serious events
Other events: 33 other events
Deaths: 0 deaths
Orteronel 300 mg (Japan)
Serious events: 18 serious events
Other events: 32 other events
Deaths: 0 deaths
Orteronel 200 mg (Ex-Japan)
Serious events: 16 serious events
Other events: 35 other events
Deaths: 0 deaths
Orteronel 400mg (Ex-Japan)
Serious events: 12 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=44 participants at risk
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Japan)
n=33 participants at risk
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=32 participants at risk
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
n=36 participants at risk
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400mg (Ex-Japan)
n=36 participants at risk
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Pneumonia
|
4.5%
2/44 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Influenza
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Investigations
Liver function test abnormal
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
1/44 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
General disorders
General physical health deterioration
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Escherichia sepsis
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Respiratory tract infection
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Septic shock
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Renal and urinary disorders
Haematuria
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
General disorders
Asthenia
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
General disorders
Fatigue
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
General disorders
Device occlusion
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Vascular disorders
Hypertension
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Nervous system disorders
Spinal cord compression
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Cardiac disorders
Atrial fibrillation
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Investigations
International normalised ratio increased
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Sepsis
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Spinal Ligament Ossification
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Nervous system disorders
Altered State Of Consciousness
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Eye disorders
Cataract
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Gastrointestinal Angiodysplasia
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Pain
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
Other adverse events
| Measure |
Placebo
n=44 participants at risk
Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Japan)
n=33 participants at risk
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 300 mg (Japan)
n=32 participants at risk
Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 200 mg (Ex-Japan)
n=36 participants at risk
Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
Orteronel 400mg (Ex-Japan)
n=36 participants at risk
Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
|
|---|---|---|---|---|---|
|
Investigations
Lipase increased
|
43.2%
19/44 • Number of events 36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
75.8%
25/33 • Number of events 46 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
59.4%
19/32 • Number of events 32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
25.0%
9/36 • Number of events 10 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
19.4%
7/36 • Number of events 9 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Investigations
Amylase increased
|
36.4%
16/44 • Number of events 21 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
63.6%
21/33 • Number of events 35 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
59.4%
19/32 • Number of events 27 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
11.1%
4/36 • Number of events 7 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
16.7%
6/36 • Number of events 10 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Constipation
|
15.9%
7/44 • Number of events 7 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
24.2%
8/33 • Number of events 9 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
31.2%
10/32 • Number of events 12 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
27.8%
10/36 • Number of events 13 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
33.3%
12/36 • Number of events 13 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
11/44 • Number of events 12 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
12.1%
4/33 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
15.6%
5/32 • Number of events 6 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
41.7%
15/36 • Number of events 30 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
36.1%
13/36 • Number of events 16 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
General disorders
Fatigue
|
18.2%
8/44 • Number of events 9 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
52.8%
19/36 • Number of events 22 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
41.7%
15/36 • Number of events 17 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
11/44 • Number of events 16 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.1%
3/33 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
25.0%
8/32 • Number of events 9 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
22.2%
8/36 • Number of events 11 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
33.3%
12/36 • Number of events 22 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Nausea
|
15.9%
7/44 • Number of events 12 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
15.2%
5/33 • Number of events 6 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
21.9%
7/32 • Number of events 10 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
36.1%
13/36 • Number of events 17 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
33.3%
12/36 • Number of events 16 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Vascular disorders
Hot flush
|
15.9%
7/44 • Number of events 7 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.1%
3/33 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
15.6%
5/32 • Number of events 5 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
13.9%
5/36 • Number of events 5 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
27.8%
10/36 • Number of events 10 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
11.4%
5/44 • Number of events 5 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
27.3%
9/33 • Number of events 10 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
18.8%
6/32 • Number of events 8 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
11.1%
4/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
13.6%
6/44 • Number of events 7 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
21.2%
7/33 • Number of events 7 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
21.9%
7/32 • Number of events 11 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
13.6%
6/44 • Number of events 8 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
21.2%
7/33 • Number of events 7 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
21.9%
7/32 • Number of events 11 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
General disorders
Oedema peripheral
|
9.1%
4/44 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
24.2%
8/33 • Number of events 10 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
18.8%
6/32 • Number of events 7 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
19.4%
7/36 • Number of events 7 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
13.9%
5/36 • Number of events 6 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.4%
5/44 • Number of events 7 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
15.6%
5/32 • Number of events 8 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
25.0%
9/36 • Number of events 10 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
19.4%
7/36 • Number of events 8 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Investigations
Gamma-glutamyltransferase increased
|
13.6%
6/44 • Number of events 6 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
15.2%
5/33 • Number of events 6 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
25.0%
8/32 • Number of events 14 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
3/44 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
12.1%
4/33 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.4%
3/32 • Number of events 11 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
25.0%
9/36 • Number of events 12 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Investigations
Weight decreased
|
11.4%
5/44 • Number of events 5 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
18.8%
6/32 • Number of events 9 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Nervous system disorders
Dysgeusia
|
6.8%
3/44 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
12.5%
4/32 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
11.1%
4/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
11.1%
4/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Vascular disorders
Hypertension
|
9.1%
4/44 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.1%
3/33 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.4%
3/32 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
22.2%
8/36 • Number of events 8 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
15.9%
7/44 • Number of events 7 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
24.2%
8/33 • Number of events 10 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
25.0%
8/32 • Number of events 13 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Investigations
Blood lactate dehydrogenase increased
|
11.4%
5/44 • Number of events 5 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
24.2%
8/33 • Number of events 8 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
12.5%
4/32 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Psychiatric disorders
Insomnia
|
4.5%
2/44 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
16.7%
6/36 • Number of events 6 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
11.1%
4/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Upper respiratory trat infection
|
9.1%
4/44 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.1%
3/33 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
12.5%
4/32 • Number of events 5 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
16.7%
6/36 • Number of events 7 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Nervous system disorders
Dizziness
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
12.5%
4/32 • Number of events 5 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
13.9%
5/36 • Number of events 5 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
9.1%
4/44 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
12.1%
4/33 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
11.1%
4/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.8%
3/44 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.4%
3/32 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
13.9%
5/36 • Number of events 6 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.1%
4/44 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
11.1%
4/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
General disorders
Malaise
|
9.1%
4/44 • Number of events 5 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
12.1%
4/33 • Number of events 5 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
18.8%
6/32 • Number of events 7 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Investigations
Blood creatinine increased
|
4.5%
2/44 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
15.6%
5/32 • Number of events 5 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
11.1%
4/36 • Number of events 5 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
4.5%
2/44 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.1%
3/33 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
15.6%
5/32 • Number of events 8 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
13.9%
5/36 • Number of events 6 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
2/44 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
11.1%
4/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
2/44 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
13.9%
5/36 • Number of events 6 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
11.1%
4/36 • Number of events 5 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
18.8%
6/32 • Number of events 7 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Investigations
Blood urea increased
|
2.3%
1/44 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
12.5%
4/32 • Number of events 8 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.4%
3/32 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
13.9%
5/36 • Number of events 5 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
11.1%
4/36 • Number of events 5 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.8%
3/44 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
6.8%
3/44 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
11.1%
4/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.1%
3/33 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Stomatitis
|
9.1%
4/44 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 7 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Cardiac disorders
Atrial fibrillation
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
4.5%
2/44 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.4%
3/32 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Renal and urinary disorders
Haematuria
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Nervous system disorders
Hypoaesthesia
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.4%
3/32 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.5%
2/44 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
13.9%
5/36 • Number of events 6 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.5%
2/44 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
11.1%
4/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
11.1%
4/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.1%
3/33 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Renal and urinary disorders
Nocturia
|
6.8%
3/44 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Psychiatric disorders
Depression
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.3%
1/44 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.4%
3/32 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.5%
2/44 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Cardiac disorders
Sinus tachycardia
|
4.5%
2/44 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
15.2%
5/33 • Number of events 6 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Investigations
White blood cell count decreased
|
6.8%
3/44 • Number of events 5 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.1%
3/33 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.4%
3/32 • Number of events 5 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
11.1%
4/36 • Number of events 5 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.1%
3/33 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Eye disorders
Cataract
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.1%
3/33 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.1%
3/33 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Chronic Gastritis
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
General disorders
Face Oedema
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
General disorders
Pyrexia
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.4%
3/32 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 5 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Cystitis
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.1%
3/33 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Influenza
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.4%
3/32 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 8 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Investigations
Weight increased
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
12.1%
4/33 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.1%
3/33 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Investigations
White blood cell count increased
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Nervous system disorders
Headache
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.1%
1/32 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.1%
3/33 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
9.4%
3/32 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.1%
2/33 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
3.0%
1/33 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
6.2%
2/32 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Eye disorders
Glaucoma
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
General disorders
Peripheral swelling
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
11.1%
4/36 • Number of events 6 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 4 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Nervous system disorders
Syncope
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Vascular disorders
Flushing
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Vascular disorders
Hypotension
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
8.3%
3/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
2.8%
1/36 • Number of events 1 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 3 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/44 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/33 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/32 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
0.00%
0/36 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
5.6%
2/36 • Number of events 2 • From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER