Trial Outcomes & Findings for A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) (NCT NCT00213135)
NCT ID: NCT00213135
Last Updated: 2014-02-07
Results Overview
A qualifying relapse was defined as an increase of 2 points in at least one functional system of the expanded disability status scale (EDSS) or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis \[MS\]) was calculated. The annualized relapse rate for each treatment group was calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1326 participants
Primary outcome timeframe
Week 96
Results posted on
2014-02-07
Participant Flow
Participant milestones
| Measure |
Cladribine 5.25 mg/kg
Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
|
Cladribine 3.5 mg/kg
Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
|
Placebo
Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
456
|
433
|
437
|
|
Overall Study
COMPLETED
|
406
|
398
|
380
|
|
Overall Study
NOT COMPLETED
|
50
|
35
|
57
|
Reasons for withdrawal
| Measure |
Cladribine 5.25 mg/kg
Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
|
Cladribine 3.5 mg/kg
Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
|
Placebo
Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
9
|
5
|
5
|
|
Overall Study
Lost to Follow-up
|
11
|
8
|
4
|
|
Overall Study
Protocol Violation
|
4
|
4
|
10
|
|
Overall Study
Death
|
1
|
1
|
2
|
|
Overall Study
Disease progression
|
4
|
5
|
21
|
|
Overall Study
Other
|
21
|
12
|
15
|
Baseline Characteristics
A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)
Baseline characteristics by cohort
| Measure |
Cladribine 5.25 mg/kg
n=456 Participants
Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
|
Cladribine 3.5 mg/kg
n=433 Participants
Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
|
Placebo
n=437 Participants
Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
|
Total
n=1326 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
37.9 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
38.7 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
38.6 years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
312 Participants
n=5 Participants
|
298 Participants
n=7 Participants
|
288 Participants
n=5 Participants
|
898 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
144 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
428 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 96Population: The intention-to-treat (ITT) population included all participants who were randomized in the study.
A qualifying relapse was defined as an increase of 2 points in at least one functional system of the expanded disability status scale (EDSS) or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis \[MS\]) was calculated. The annualized relapse rate for each treatment group was calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Outcome measures
| Measure |
Cladribine 5.25 mg/kg
n=456 Participants
Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
|
Cladribine 3.5 mg/kg
n=433 Participants
Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
|
Placebo
n=437 Participants
Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
|
|---|---|---|---|
|
Annualized Qualifying Relapse Rate
|
0.15 relapses per year
95% Confidence Interval 0.58 • Interval 0.12 to 0.17
|
0.14 relapses per year
95% Confidence Interval 0.59 • Interval 0.12 to 0.17
|
0.33 relapses per year
95% Confidence Interval 0.88 • Interval 0.29 to 0.38
|
SECONDARY outcome
Timeframe: Week 96Population: The ITT population included all participants who were randomized in the study.
A qualifying relapse was defined as an increase of 2 points in at least one functional system of the EDSS or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.
Outcome measures
| Measure |
Cladribine 5.25 mg/kg
n=456 Participants
Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
|
Cladribine 3.5 mg/kg
n=433 Participants
Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
|
Placebo
n=437 Participants
Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
|
|---|---|---|---|
|
Percentage of Relapse-free Participants
|
78.9 percentage of participants
|
79.7 percentage of participants
|
60.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 96Population: The ITT population included all participants who were randomized in the study.
Time to disability progression was defined as the time to a sustained increase in EDSS score of at least 1 point if baseline EDSS score between 0.5 and 4.5 inclusively, or at least 1.5 points if the baseline EDSS score was 0, or at least 0.5 point if the baseline EDSS score was at least 5, over a period of at least three months. Expanded disability status scale (EDSS) assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. Tenth Percentile of time to sustained increase in EDSS score was reported using Kaplan-Meier survival curve.
Outcome measures
| Measure |
Cladribine 5.25 mg/kg
n=456 Participants
Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
|
Cladribine 3.5 mg/kg
n=433 Participants
Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
|
Placebo
n=437 Participants
Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
|
|---|---|---|---|
|
Time to Disability Progression
|
13.6 months
|
13.6 months
|
10.8 months
|
SECONDARY outcome
Timeframe: Week 96Population: The ITT population included all participants who were randomized in the study.
Mean Number of CU lesions, active T2 lesions, and active T1 Gd+ lesions were measured by using magnetic resonance imaging (MRI) scans.
Outcome measures
| Measure |
Cladribine 5.25 mg/kg
n=456 Participants
Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
|
Cladribine 3.5 mg/kg
n=433 Participants
Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
|
Placebo
n=437 Participants
Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
|
|---|---|---|---|
|
Mean Number of Combined Unique (CU) Lesions, Active Time Constant 2 (T2) Lesions, and Active Time Constant 1 (T1) Gadolinium-Enhanced (Gd+) Lesions Per Participant Per Scan
CU lesions
|
0.38 lesions
Standard Error 0.08
|
0.43 lesions
Standard Error 0.08
|
1.72 lesions
Standard Error 0.08
|
|
Mean Number of Combined Unique (CU) Lesions, Active Time Constant 2 (T2) Lesions, and Active Time Constant 1 (T1) Gadolinium-Enhanced (Gd+) Lesions Per Participant Per Scan
Active T2 lesions
|
0.33 lesions
Standard Error 0.06
|
0.38 lesions
Standard Error 0.07
|
1.43 lesions
Standard Error 0.06
|
|
Mean Number of Combined Unique (CU) Lesions, Active Time Constant 2 (T2) Lesions, and Active Time Constant 1 (T1) Gadolinium-Enhanced (Gd+) Lesions Per Participant Per Scan
Active T1 Gd+ lesions
|
0.11 lesions
Standard Error 0.05
|
0.12 lesions
Standard Error 0.05
|
0.91 lesions
Standard Error 0.05
|
Adverse Events
Cladribine 5.25 mg/kg
Serious events: 41 serious events
Other events: 324 other events
Deaths: 0 deaths
Cladribine 3.5 mg/kg
Serious events: 36 serious events
Other events: 286 other events
Deaths: 0 deaths
Placebo
Serious events: 28 serious events
Other events: 242 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cladribine 5.25 mg/kg
n=454 participants at risk
Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
|
Cladribine 3.5 mg/kg
n=430 participants at risk
Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
|
Placebo
n=435 participants at risk
Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.66%
3/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.70%
3/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.69%
3/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Adnexitis
|
0.44%
2/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Appendicitis
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.46%
2/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.47%
2/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Urinary tract infection
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Actinomycosis
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Cystitis
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Endometritis
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Herpes zoster infection neurological
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Herpes zoster oticus
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Influenza
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Lung abscess
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Myocarditis bacterial
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Orchitis
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Respiratory tract infection
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Salpingo-oophoritis
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Tuberculosis
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.44%
2/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Hepatobiliary disorders
Cholecystitis
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Hepatobiliary disorders
Hepatitis
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Gastrointestinal disorders
Ileus
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Gastrointestinal disorders
Nausea
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Gastrointestinal disorders
Toothache
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Gastrointestinal disorders
Vomiting
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.47%
2/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.47%
2/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.44%
2/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.70%
3/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Psychiatric disorders
Suicide attempt
|
0.44%
2/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Psychiatric disorders
Delirium
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Psychiatric disorders
Depression
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Cardiac disorders
Cardiac hypertrophy
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Cardiac disorders
Prinzmetal angina
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
General disorders
Chest pain
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
General disorders
Pyrexia
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
General disorders
Asthenia
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
General disorders
Drowning
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
General disorders
Non-cardiac chest pain
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
General disorders
Oedema peripheral
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.44%
2/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Nervous system disorders
Convulsion
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Nervous system disorders
Epilepsy
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Nervous system disorders
Facial spasm
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Nervous system disorders
Syncope
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.70%
3/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Renal and urinary disorders
Nephrosclerosis
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Reproductive system and breast disorders
Breast dysplasia
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Skin and subcutaneous tissue disorders
Lichen sclerosus
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Vascular disorders
Arterial disorder
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Vascular disorders
Deep vein thrombosis
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Vascular disorders
Hypertension
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Immune system disorders
Hypersensitivity
|
0.44%
2/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Metabolism and nutrition disorders
Cachexia
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Endocrine disorders
Hyperthyroidism
|
0.22%
1/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.23%
1/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
Other adverse events
| Measure |
Cladribine 5.25 mg/kg
n=454 participants at risk
Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
|
Cladribine 3.5 mg/kg
n=430 participants at risk
Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
|
Placebo
n=435 participants at risk
Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
23/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
6.3%
27/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
4.8%
21/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.6%
39/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
7.9%
34/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
6.4%
28/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Psychiatric disorders
Depression
|
5.5%
25/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
4.2%
18/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
3.0%
13/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
31/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
7.0%
30/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
6.7%
29/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
General disorders
Fatigue
|
5.9%
27/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
4.7%
20/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
6.0%
26/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Nervous system disorders
Headache
|
20.7%
94/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
24.2%
104/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
17.2%
75/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Influenza
|
7.5%
34/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
6.3%
27/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
6.2%
27/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
General disorders
Influenza like illness
|
5.9%
27/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
7.9%
34/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
7.1%
31/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Psychiatric disorders
Insomnia
|
3.1%
14/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
5.8%
25/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
3.9%
17/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.6%
39/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
5.3%
23/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.69%
3/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Investigations
Lymphocyte count decreased
|
5.7%
26/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
3.0%
13/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
0.00%
0/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Blood and lymphatic system disorders
Lymphopenia
|
31.3%
142/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
21.4%
92/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
1.8%
8/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Nasopharyngitis
|
12.8%
58/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
14.4%
62/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
12.9%
56/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Gastrointestinal disorders
Nausea
|
10.8%
49/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
10.0%
43/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
9.0%
39/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
24/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
3.7%
16/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
4.6%
20/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
24/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
4.4%
19/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
5.7%
25/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Upper respiratory tract infection
|
11.5%
52/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
12.6%
54/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
9.7%
42/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Infections and infestations
Urinary tract infection
|
7.0%
32/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
5.3%
23/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
9.0%
39/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
|
Ear and labyrinth disorders
Vertigo
|
5.1%
23/454 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
3.3%
14/430 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
2.5%
11/435 • Baseline up to Week 96
Safety population included all the randomized participants who received at least one dose of stud medication with follow-up safety data
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER