Trial Outcomes & Findings for A 24-week Off-drug Extension Study in Sarcopenic Elderly Who Completed Treatment in the 6-month Core Study (NCT NCT02468674)
NCT ID: NCT02468674
Last Updated: 2020-06-16
Results Overview
SPPB evaluates lower extremities in three functional components: maintenance of standing balance, usual gait speed and chair stand. Each test yields a score on a scale from 0 to 4 (total score 0-12, with the higher score reflecting a higher level of function).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
160 participants
Primary outcome timeframe
Week 49
Results posted on
2020-06-16
Participant Flow
This study was conducted in 30 centers in 12 countries: Australia (1), Belgium (1), Czech Republic (1), Denmark (1), France (2), Japan (10), Russia (4), South Korea (1), Spain (2), Switzerland (1), Taiwan (1), United States (5).
Participant milestones
| Measure |
Population I: BYM338 700 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 700 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 210 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 210 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population: II BYM338 700 mg
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
|
Population: II Placebo
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
4
|
7
|
7
|
15
|
69
|
43
|
|
Overall Study
COMPLETED
|
4
|
5
|
5
|
3
|
6
|
6
|
14
|
65
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
1
|
1
|
1
|
4
|
3
|
Reasons for withdrawal
| Measure |
Population I: BYM338 700 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 700 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 210 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 210 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population: II BYM338 700 mg
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
|
Population: II Placebo
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Patient/Guardian Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
1
|
|
Overall Study
Protocol Deviation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
Baseline characteristics by cohort
| Measure |
Population I: BYM338 700 mg
n=5 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 700 mg to Placebo
n=5 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 210 mg
n=5 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 210 mg to Placebo
n=4 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg
n=7 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg to Placebo
n=7 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: Placebo
n=15 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population: II BYM338 700 mg
n=69 Participants
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
|
Population: II Placebo
n=43 Participants
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
Caucasian
|
4 Participants
n=5 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
5 Participants
n=5 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
5 Participants
n=5 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
3 Participants
n=4 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
4 Participants
n=7 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
4 Participants
n=7 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
8 Participants
n=15 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
56 Participants
n=69 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
40 Participants
n=43 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
96 Participants
n=112 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0 Participants
n=5 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0 Participants
n=5 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
1 Participants
n=4 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
2 Participants
n=7 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
2 Participants
n=7 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
6 Participants
n=15 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
11 Participants
n=69 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
3 Participants
n=43 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
12 Participants
n=48 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
|
Age, Continuous
|
80.0 Years
STANDARD_DEVIATION 4.90 • n=5 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
79.4 Years
STANDARD_DEVIATION 7.27 • n=5 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
79.0 Years
STANDARD_DEVIATION 1.58 • n=5 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
74.8 Years
STANDARD_DEVIATION 2.63 • n=4 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
77.6 Years
STANDARD_DEVIATION 6.75 • n=7 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
81.6 Years
STANDARD_DEVIATION 4.58 • n=7 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
79.9 Years
STANDARD_DEVIATION 4.22 • n=15 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
79.8 Years
STANDARD_DEVIATION 5.05 • n=69 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
78.2 Years
STANDARD_DEVIATION 5.29 • n=43 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
79.2 Years
STANDARD_DEVIATION 5.18 • n=112 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
|
Sex: Female, Male
Female
|
0 Participants
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0 Participants
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0 Participants
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0 Participants
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0 Participants
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0 Participants
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0 Participants
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
40 Participants
n=69 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
29 Participants
n=43 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
69 Participants
n=112 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
|
Sex: Female, Male
Male
|
0 Participants
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0 Participants
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0 Participants
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0 Participants
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0 Participants
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0 Participants
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0 Participants
160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
29 Participants
n=69 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
14 Participants
n=43 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
43 Participants
n=112 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0 Participants
n=5 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0 Participants
n=5 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0 Participants
n=4 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
1 Participants
n=7 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
1 Participants
n=7 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
1 Participants
n=15 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
—
|
—
|
3 Participants
n=48 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
|
Race/Ethnicity, Customized
Native American
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=69 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0 Participants
n=43 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
1 Participants
n=112 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
|
Race/Ethnicity, Customized
Pacific Islander
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=69 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0 Participants
n=43 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
1 Participants
n=112 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
|
Population I: Short Physical Performance Battery (SPPB) total score at Week 25
|
8.8 Scores on a scale
STANDARD_DEVIATION 2.17 • n=5 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
10.4 Scores on a scale
STANDARD_DEVIATION 1.34 • n=5 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
8.6 Scores on a scale
STANDARD_DEVIATION 1.67 • n=5 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
8.5 Scores on a scale
STANDARD_DEVIATION 1.91 • n=4 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
8.9 Scores on a scale
STANDARD_DEVIATION 2.04 • n=7 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
8.0 Scores on a scale
STANDARD_DEVIATION 3.27 • n=7 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
9.1 Scores on a scale
STANDARD_DEVIATION 1.58 • n=15 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
—
|
—
|
8.9 Scores on a scale
STANDARD_DEVIATION 2.01 • n=48 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
|
Population II: Short Physical Performance Battery (SPPB) total score at Week 25
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8.5 Scores on a scale
STANDARD_DEVIATION 2.17 • n=69 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
8.2 Scores on a scale
STANDARD_DEVIATION 2.25 • n=43 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
8.4 Scores on a scale
STANDARD_DEVIATION 2.20 • n=112 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
|
Population I: 6-minute walking distance (6MWT) at Week 25
|
302.73 meters
STANDARD_DEVIATION 130.22 • n=5 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
353.10 meters
STANDARD_DEVIATION 66.17 • n=5 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
313.67 meters
STANDARD_DEVIATION 71.39 • n=5 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
361.07 meters
STANDARD_DEVIATION 80.11 • n=4 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
305.24 meters
STANDARD_DEVIATION 111.34 • n=7 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
286.94 meters
STANDARD_DEVIATION 119.37 • n=7 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
352.18 meters
STANDARD_DEVIATION 123.55 • n=15 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
—
|
—
|
327.49 meters
STANDARD_DEVIATION 106.64 • n=48 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
|
Population II: 6-minute walking distance (6MWT) at Week 25
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
307.84 meters
STANDARD_DEVIATION 99.96 • n=69 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
315.61 meters
STANDARD_DEVIATION 95.74 • n=43 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
310.81 meters
STANDARD_DEVIATION 98.01 • n=112 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
|
Population I: Gait speed at Week 25
|
0.8 m/sec
STANDARD_DEVIATION 0.20 • n=5 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0.9 m/sec
STANDARD_DEVIATION 0.13 • n=5 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0.9 m/sec
STANDARD_DEVIATION 0.27 • n=5 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0.9 m/sec
STANDARD_DEVIATION 0.12 • n=4 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0.8 m/sec
STANDARD_DEVIATION 0.19 • n=7 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0.6 m/sec
STANDARD_DEVIATION 0.28 • n=7 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0.8 m/sec
STANDARD_DEVIATION 0.19 • n=15 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
—
|
—
|
0.8 m/sec
STANDARD_DEVIATION 0.21 • n=48 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
|
Population II: Gait speed at Week 25
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.8 m/sec
STANDARD_DEVIATION 0.23 • n=69 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0.8 m/sec
STANDARD_DEVIATION 0.22 • n=43 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
0.8 m/sec
STANDARD_DEVIATION 0.22 • n=112 Participants • 160 participants were enrolled into the study: 48 in Population I (patients enrolled prior to protocol amendment 1) and 112 in Population II (patients enrolled after protocol amendment 1)
|
PRIMARY outcome
Timeframe: Week 49Population: The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.
SPPB evaluates lower extremities in three functional components: maintenance of standing balance, usual gait speed and chair stand. Each test yields a score on a scale from 0 to 4 (total score 0-12, with the higher score reflecting a higher level of function).
Outcome measures
| Measure |
Population I: BYM338 700 mg
n=4 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 700 mg to Placebo
n=5 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 210 mg
n=5 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 210 mg to Placebo
n=3 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg
n=6 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg to Placebo
n=6 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: Placebo
n=14 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49
|
8.8 Scores on a scale
Standard Deviation 3.86
|
10.2 Scores on a scale
Standard Deviation 1.92
|
8.0 Scores on a scale
Standard Deviation 2.35
|
8.0 Scores on a scale
Standard Deviation 2.65
|
9.5 Scores on a scale
Standard Deviation 2.17
|
7.5 Scores on a scale
Standard Deviation 3.78
|
9.6 Scores on a scale
Standard Deviation 1.83
|
PRIMARY outcome
Timeframe: Week 49Population: The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.
SPPB evaluates lower extremities in three functional components: maintenance of standing balance, usual gait speed and chair stand. Each test yields a score on a scale from 0 to 4 (total score 0-12, with the higher score reflecting a higher level of function).
Outcome measures
| Measure |
Population I: BYM338 700 mg
n=65 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 700 mg to Placebo
n=40 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 210 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 210 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Population II: Short Physical Performance Battery (SPPB) Total Score at Week 49
|
8.6 Scores on a scale
Standard Deviation 2.40
|
8.8 Scores on a scale
Standard Deviation 1.55
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 49Population: The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.
The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. A high 6MWT represent better physical condition.
Outcome measures
| Measure |
Population I: BYM338 700 mg
n=5 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 700 mg to Placebo
n=5 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 210 mg
n=5 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 210 mg to Placebo
n=4 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg
n=7 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg to Placebo
n=7 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: Placebo
n=15 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Population I: 6-minute Walking Distance (6MWT) at Week 49
|
318.2 meters
Standard Deviation 159.55
|
354.1 meters
Standard Deviation 69.98
|
304.1 meters
Standard Deviation 63.05
|
361.5 meters
Standard Deviation 144.53
|
316.1 meters
Standard Deviation 97.87
|
273.4 meters
Standard Deviation 154.03
|
368.7 meters
Standard Deviation 108.37
|
SECONDARY outcome
Timeframe: Week 49Population: The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.
The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. A high 6MWT represent better physical condition.
Outcome measures
| Measure |
Population I: BYM338 700 mg
n=69 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 700 mg to Placebo
n=43 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 210 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 210 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Population II: 6-minute Walking Distance (6MWT) at Week 49
|
321.2 meters
Standard Deviation 105.13
|
323.1 meters
Standard Deviation 96.47
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 49Population: The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.
Gait Speed was assessed as part of SPPB, over a 4 meter distance of a 6 meter course. Gait speed assesses a person's usual walking speed, which is defined as the speed a person normally walks from one place to another. Poor functional performance is measured by slow or declining gait speed.
Outcome measures
| Measure |
Population I: BYM338 700 mg
n=5 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 700 mg to Placebo
n=5 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 210 mg
n=5 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 210 mg to Placebo
n=4 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg
n=7 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg to Placebo
n=7 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: Placebo
n=15 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Population I: Gait Speed at Week 49
|
0.8 m/sec
Standard Deviation 0.35
|
1.0 m/sec
Standard Deviation 0.18
|
0.9 m/sec
Standard Deviation 0.17
|
1.1 m/sec
Standard Deviation 0.24
|
0.9 m/sec
Standard Deviation 0.15
|
0.7 m/sec
Standard Deviation 0.35
|
0.8 m/sec
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: Week 49Population: The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.
Gait Speed was assessed as part of SPPB, over a 4 meter distance of a 6 meter course. Gait speed assesses a person's usual walking speed, which is defined as the speed a person normally walks from one place to another. Poor functional performance is measured by slow or declining gait speed.
Outcome measures
| Measure |
Population I: BYM338 700 mg
n=69 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 700 mg to Placebo
n=43 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 210 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 210 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Population II: Gait Speed at Week 49
|
0.9 m/sec
Standard Deviation 0.24
|
0.9 m/sec
Standard Deviation 0.17
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 49Population: The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.
ASMI is a core requirement for determining the presence of sarcopenia and is calculated as the sum of the appendicular lean mass (kg) of the two upper and two lower limbs quantified by DXA, divided by height (m2). Therefore, an increase in ASMI indicates an increase in the quantity of an individual's lean mass.
Outcome measures
| Measure |
Population I: BYM338 700 mg
n=5 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 700 mg to Placebo
n=5 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 210 mg
n=5 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 210 mg to Placebo
n=4 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg
n=7 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg to Placebo
n=7 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: Placebo
n=15 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Population I: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
|
6.6 kg/m^2
Geometric Coefficient of Variation 7.22
|
6.0 kg/m^2
Geometric Coefficient of Variation 14.05
|
6.1 kg/m^2
Geometric Coefficient of Variation 8.08
|
5.8 kg/m^2
Geometric Coefficient of Variation 15.08
|
5.9 kg/m^2
Geometric Coefficient of Variation 14.19
|
5.2 kg/m^2
Geometric Coefficient of Variation 14.85
|
5.6 kg/m^2
Geometric Coefficient of Variation 15.21
|
SECONDARY outcome
Timeframe: Week 49Population: The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.
ASMI is a core requirement for determining the presence of sarcopenia and is calculated as the sum of the appendicular lean mass (kg) of the two upper and two lower limbs quantified by DXA, divided by height (m2). Therefore, an increase in ASMI indicates an increase in the quantity of an individual's lean mass.
Outcome measures
| Measure |
Population I: BYM338 700 mg
n=69 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 700 mg to Placebo
n=43 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 210 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 210 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Population II: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
|
5.6 kg/m^2
Geometric Coefficient of Variation 14.36
|
5.5 kg/m^2
Geometric Coefficient of Variation 12.46
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 49Population: The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.
LBM is defined as the Total soft tissue fat-free body mass. A high LBM represents better pharmacodynamic effect
Outcome measures
| Measure |
Population I: BYM338 700 mg
n=5 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 700 mg to Placebo
n=5 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 210 mg
n=5 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 210 mg to Placebo
n=4 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg
n=7 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg to Placebo
n=7 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: Placebo
n=15 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Population I: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
|
41.4 kg
Geometric Coefficient of Variation 21.11
|
34.0 kg
Geometric Coefficient of Variation 17.76
|
35.5 kg
Geometric Coefficient of Variation 15.39
|
32.6 kg
Geometric Coefficient of Variation 25.23
|
34.9 kg
Geometric Coefficient of Variation 21.16
|
34.0 kg
Geometric Coefficient of Variation 18.47
|
32.6 kg
Geometric Coefficient of Variation 17.95
|
SECONDARY outcome
Timeframe: Week 49Population: The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.
LBM is defined as the Total soft tissue fat-free body mass. A high LBM represents better pharmacodynamic effect
Outcome measures
| Measure |
Population I: BYM338 700 mg
n=69 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 700 mg to Placebo
n=43 Participants
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 210 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338: 210 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: BYM338 70 mg to Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I: Placebo
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Population II: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49
|
34.9 kg
Geometric Coefficient of Variation 25.01
|
33.7 kg
Geometric Coefficient of Variation 20.40
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Population I BYM338 700 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Population I BYM338 700 mg to Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Population I BYM338 210 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Population I BYM338 210 mg to Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Population I BYM338 70 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Population I BYM338 70 mg to Placebo
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Population I Placebo
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Population: II BYM338 700 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Population: II Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Population I BYM338 700 mg
n=5 participants at risk
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338 700 mg to Placebo
n=5 participants at risk
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338 210 mg
n=5 participants at risk
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338 210 mg to Placebo
n=4 participants at risk
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338 70 mg
n=7 participants at risk
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338 70 mg to Placebo
n=7 participants at risk
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I Placebo
n=15 participants at risk
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population: II BYM338 700 mg
n=69 participants at risk
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
|
Population: II Placebo
n=43 participants at risk
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
14.3%
1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
14.3%
1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
14.3%
1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
14.3%
1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Nervous system disorders
Seizure
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
Other adverse events
| Measure |
Population I BYM338 700 mg
n=5 participants at risk
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338 700 mg to Placebo
n=5 participants at risk
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338 210 mg
n=5 participants at risk
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338 210 mg to Placebo
n=4 participants at risk
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338 70 mg
n=7 participants at risk
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I BYM338 70 mg to Placebo
n=7 participants at risk
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population I Placebo
n=15 participants at risk
Follow-up (arm 1): Patients in Population I received 6 doses of bimagrumab 70 mg, 210 mg, 700 mg or placebo - one approximately every four weeks - over a 20-week period providing drug exposure for a total of 24 weeks.
|
Population: II BYM338 700 mg
n=69 participants at risk
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
|
Population: II Placebo
n=43 participants at risk
Follow-up (arm 2): Patients in Population II received either bimagrumab 700 mg or placebo in the core study and did not receive any investigational treatment in the extension study.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Eye disorders
Dry eye
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Eye disorders
Eye irritation
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
14.3%
1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
14.3%
1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Gastrointestinal disorders
Chronic gastritis
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
14.3%
1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
14.3%
1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Gastrointestinal disorders
Large intestine polyp
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
General disorders
Fatigue
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
General disorders
Influenza like illness
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
General disorders
Peripheral swelling
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Infections and infestations
Cystitis
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
14.3%
1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
28.6%
2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Infections and infestations
Rhinitis
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
14.3%
1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
14.3%
1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
28.6%
2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
40.0%
6/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
14.3%
1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
14.3%
1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Investigations
Body mass index decreased
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Investigations
Lipase increased
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
28.6%
2/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
14.3%
1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
14.3%
1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Product Issues
Device loosening
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
13.3%
2/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
14.3%
1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
14.3%
1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Renal and urinary disorders
Nephrolithiasis
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Renal and urinary disorders
Renal cyst
|
20.0%
1/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Reproductive system and breast disorders
Prostatic dysplasia
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
25.0%
1/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
6.7%
1/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/5 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
14.3%
1/7 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/15 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/69 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
0.00%
0/43 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum treatment duration of 24 weeks
Adverse events presented below are events considered to be treatment-emergent, therefore only events occurring in Population I are summarized. Patients in Population II did not receive study medication (were followed-up of-drug), thus any events occurring in this group were not treatment-emergent and are not captured in the summary.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER