Trial Outcomes & Findings for Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease (NCT NCT03352557)
NCT ID: NCT03352557
Last Updated: 2022-11-08
Results Overview
AE is any untoward medical occurrence in participant or clinical investigation participant administered pharmaceutical product and that does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal (investigational) product, whether or not related to medicinal (investigational) product. SAE is any untoward medical occurrence that at any dose, results in death; in view of investigator places participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect; is medically important event. Participants who completed treatment period in PC period and did not enter LTE period were to be assessed at Week 90 (14 weeks after end of treatment) as safety follow-up.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
654 participants
Primary outcome timeframe
Day 1 to Week 78 (participants who entered LTE period); Day 1 up to Week 90 (participants who did not LTE period)
Results posted on
2022-11-08
Participant Flow
Participants were enrolled at approximately 100 investigational sites from 03 May 2018 to 30 August 2021.
A total of 654 participants with Alzheimer's Disease (AD) were enrolled and randomized to receive placebo or BIIB092 125/375/600/2000 milligrams(mg) in Placebo-Controlled (PC) period. Following PC period, 521 participants entered and 516 were dosed in Long-term Extension (LTE) period, and no participants completed the study due to early termination of the study. WBP/G=Withdrawal by Parent/Guardian
Participant milestones
| Measure |
PC Period: Placebo
Participants received BIIB092-matching placebo, intravenous (IV) infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 125 mg/4 Week
Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 375 mg/12 Week
Participants received BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 600 mg/4 Week
Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 2000 mg/4 Week
Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
LTE Period: BIIB092 125 mg/4 Week
Participants who received BIIB092, 125 mg, IV infusion during the PC period, continued to receive BIIB092, 125 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
|
LTE Period: BIIB092 375 mg/12 Week
Participants who received BIIB092, 375 mg, IV infusion during the PC period, continued to receive BIIB092, 375 mg, IV infusion once every 12 weeks from Week 80 to Week 155 during the LTE period.
|
LTE Period: BIIB092 600 mg/4 Week
Participants who received BIIB092, 600 mg, IV infusion during the PC period, continued to receive BIIB092, 600 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
|
LTE Period: BIIB092 2000 mg/4 Week - Early Start
Participants who received BIIB092, 2000 mg, IV infusion during the PC period, continued to receive BIIB092, 2000 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
|
LTE Period: BIIB092 2000 mg/4 Week - Late Start
Participants who received BIIB092-matching placebo, IV infusion during the PC period, received BIIB092, 2000 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PC Period: Day 1 to Week 78
STARTED
|
214
|
58
|
58
|
106
|
218
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
Safety Analysis Set
|
214
|
58
|
58
|
106
|
214
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
Full Analysis Set (FAS)
|
214
|
58
|
58
|
106
|
214
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
Antidrug Antibody (ADA) Evaluable Set
|
211
|
57
|
57
|
105
|
212
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
COMPLETED
|
172
|
48
|
50
|
91
|
175
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
NOT COMPLETED
|
42
|
10
|
8
|
15
|
43
|
0
|
0
|
0
|
0
|
0
|
|
LTE Period: Week 80 to Week 173
STARTED
|
0
|
0
|
0
|
0
|
0
|
46
|
49
|
90
|
169
|
167
|
|
LTE Period: Week 80 to Week 173
Safety Analysis Set
|
0
|
0
|
0
|
0
|
0
|
45
|
49
|
89
|
168
|
165
|
|
LTE Period: Week 80 to Week 173
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
LTE Period: Week 80 to Week 173
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
46
|
49
|
90
|
169
|
167
|
Reasons for withdrawal
| Measure |
PC Period: Placebo
Participants received BIIB092-matching placebo, intravenous (IV) infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 125 mg/4 Week
Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 375 mg/12 Week
Participants received BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 600 mg/4 Week
Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 2000 mg/4 Week
Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
LTE Period: BIIB092 125 mg/4 Week
Participants who received BIIB092, 125 mg, IV infusion during the PC period, continued to receive BIIB092, 125 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
|
LTE Period: BIIB092 375 mg/12 Week
Participants who received BIIB092, 375 mg, IV infusion during the PC period, continued to receive BIIB092, 375 mg, IV infusion once every 12 weeks from Week 80 to Week 155 during the LTE period.
|
LTE Period: BIIB092 600 mg/4 Week
Participants who received BIIB092, 600 mg, IV infusion during the PC period, continued to receive BIIB092, 600 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
|
LTE Period: BIIB092 2000 mg/4 Week - Early Start
Participants who received BIIB092, 2000 mg, IV infusion during the PC period, continued to receive BIIB092, 2000 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
|
LTE Period: BIIB092 2000 mg/4 Week - Late Start
Participants who received BIIB092-matching placebo, IV infusion during the PC period, received BIIB092, 2000 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PC Period: Day 1 to Week 78
Death
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
Adverse Event
|
10
|
1
|
1
|
0
|
5
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
Progressive Disease
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
Noncompliance with Study Drug
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
Protocol Deviation
|
1
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
Randomized by Mistake
|
2
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
Site Terminated by Sponsor
|
2
|
1
|
1
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
Withdrawal by Participant-Study Visit Burden/Scheduling Conflicts
|
7
|
1
|
1
|
0
|
5
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
Withdrawal by Participant-Concern About Study Procedures/Perceived Risks
|
1
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
Withdrawal by Participant-Relocation (Moving or Has Moved)
|
1
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
Withdrawal by Participant-Desire for Change in Treatment (Unrelated to Safety)
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
Withdrawal by Participant-Other
|
6
|
2
|
2
|
5
|
7
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
WBP/G-Study Visit Burden/Scheduling Conflicts
|
0
|
0
|
0
|
1
|
3
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
WBP/G-Concern About Study Procedures/Perceived Risks
|
1
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
WBP/G-Desire for Change in Treatment (Unrelated to Safety)
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
WBP/G-Unable to Continue to Enable Participation due to Illness/Hospitalization/Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
WBP/G-Other
|
0
|
2
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
Physician Decision-Unrelated to Safety
|
2
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
Lost to Follow-up
|
1
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
Other
|
5
|
1
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PC Period: Day 1 to Week 78
Not Dosed
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
|
LTE Period: Week 80 to Week 173
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
1
|
|
LTE Period: Week 80 to Week 173
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
|
LTE Period: Week 80 to Week 173
Site Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
LTE Period: Week 80 to Week 173
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
38
|
49
|
75
|
151
|
154
|
|
LTE Period: Week 80 to Week 173
Withdrawal by Participant-Study Visit Burden/Scheduling Conflicts
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
5
|
3
|
3
|
|
LTE Period: Week 80 to Week 173
Withdrawal by Participant-Relocation (Moving or Has Moved)
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
|
LTE Period: Week 80 to Week 173
Withdrawal by Participant-Other
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
4
|
|
LTE Period: Week 80 to Week 173
WBP/G-Study Visit Burden/Scheduling Conflicts
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
|
LTE Period: Week 80 to Week 173
WBP/G-Concern About Study Procedures/Perceived Risks
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
LTE Period: Week 80 to Week 173
WBP/G-Relocation (Moving or Has Moved)
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
LTE Period: Week 80 to Week 173
WBP/G-Unable to Continue to Enable Participation due to Illness/Hospitalization/Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
|
LTE Period: Week 80 to Week 173
WBP/G-Other
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
0
|
|
LTE Period: Week 80 to Week 173
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
LTE Period: Week 80 to Week 173
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
|
LTE Period: Week 80 to Week 173
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
|
LTE Period: Week 80 to Week 173
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
PC Period: Placebo
n=214 Participants
Participants received BIIB092-matching placebo, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 125 mg/4 Week
n=58 Participants
Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 375 mg/12 Week
n=58 Participants
Participants received BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 600 mg/4 Week
n=106 Participants
Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 2000 mg/4 Week
n=218 Participants
Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
Total
n=654 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.8 years
STANDARD_DEVIATION 6.63 • n=5 Participants
|
70.4 years
STANDARD_DEVIATION 6.80 • n=7 Participants
|
70.3 years
STANDARD_DEVIATION 6.79 • n=5 Participants
|
69.7 years
STANDARD_DEVIATION 6.66 • n=4 Participants
|
69.4 years
STANDARD_DEVIATION 7.11 • n=21 Participants
|
69.7 years
STANDARD_DEVIATION 6.81 • n=8 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
114 Participants
n=21 Participants
|
329 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
104 Participants
n=21 Participants
|
325 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
208 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
208 Participants
n=21 Participants
|
627 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
201 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
206 Participants
n=21 Participants
|
611 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Week 78 (participants who entered LTE period); Day 1 up to Week 90 (participants who did not LTE period)Population: The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo).
AE is any untoward medical occurrence in participant or clinical investigation participant administered pharmaceutical product and that does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal (investigational) product, whether or not related to medicinal (investigational) product. SAE is any untoward medical occurrence that at any dose, results in death; in view of investigator places participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect; is medically important event. Participants who completed treatment period in PC period and did not enter LTE period were to be assessed at Week 90 (14 weeks after end of treatment) as safety follow-up.
Outcome measures
| Measure |
PC Period: Placebo
n=214 Participants
Participants received BIIB092-matching placebo, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 125 mg/4 Week
n=58 Participants
Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 375 mg/12 Week
n=58 Participants
Participants received BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 600 mg/4 Week
n=106 Participants
Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 2000 mg/4 Week
n=214 Participants
Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
|---|---|---|---|---|---|
|
PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
12.1 percentage of participants
|
10.3 percentage of participants
|
10.3 percentage of participants
|
12.3 percentage of participants
|
11.7 percentage of participants
|
|
PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
84.6 percentage of participants
|
86.2 percentage of participants
|
82.8 percentage of participants
|
88.7 percentage of participants
|
88.3 percentage of participants
|
PRIMARY outcome
Timeframe: From Week 80 to Week 173Population: The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo).
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose, results in death; in the view of the investigator places the participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event.
Outcome measures
| Measure |
PC Period: Placebo
n=45 Participants
Participants received BIIB092-matching placebo, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 125 mg/4 Week
n=49 Participants
Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 375 mg/12 Week
n=89 Participants
Participants received BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 600 mg/4 Week
n=168 Participants
Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 2000 mg/4 Week
n=165 Participants
Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
|---|---|---|---|---|---|
|
LTE Period: Percentage of Participants With AEs and SAEs
AEs
|
68.9 percentage of participants
|
55.1 percentage of participants
|
58.4 percentage of participants
|
61.3 percentage of participants
|
60.0 percentage of participants
|
|
LTE Period: Percentage of Participants With AEs and SAEs
SAEs
|
11.1 percentage of participants
|
2.0 percentage of participants
|
10.1 percentage of participants
|
6.0 percentage of participants
|
7.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 78Population: FAS included all randomized participants who received study treatment (BIIB092 or placebo). As pre-specified in study protocol, 125 mg and 375 mg groups were pooled as 'Low dose' group for efficacy analyses.
The CDR-SB is a validated clinical assessment of global function in participants with AD. The CDR is comprised of 6 domains: Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care. CDR-SB is the sum of the scores for these 6 domains. Impairment is scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or "box scores", can be added together to give the CDR-SB score which ranges from 0 (none) to 18 (severe impairment).
Outcome measures
| Measure |
PC Period: Placebo
n=214 Participants
Participants received BIIB092-matching placebo, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 125 mg/4 Week
n=116 Participants
Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 375 mg/12 Week
n=106 Participants
Participants received BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 600 mg/4 Week
n=214 Participants
Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 2000 mg/4 Week
Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
|---|---|---|---|---|---|
|
PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score
Baseline
|
3.07 score on a scale
Standard Deviation 1.467
|
2.92 score on a scale
Standard Deviation 1.620
|
3.24 score on a scale
Standard Deviation 1.557
|
3.04 score on a scale
Standard Deviation 1.378
|
—
|
|
PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score
Change at Week 78
|
1.71 score on a scale
Standard Deviation 2.376
|
2.10 score on a scale
Standard Deviation 2.375
|
2.23 score on a scale
Standard Deviation 2.987
|
1.76 score on a scale
Standard Deviation 2.038
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 76Population: The ADA evaluable set is defined as participants in the FAS who have an evaluable postbaseline ADA sample.
Outcome measures
| Measure |
PC Period: Placebo
n=211 Participants
Participants received BIIB092-matching placebo, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 125 mg/4 Week
n=57 Participants
Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 375 mg/12 Week
n=57 Participants
Participants received BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 600 mg/4 Week
n=105 Participants
Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 2000 mg/4 Week
n=212 Participants
Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
|---|---|---|---|---|---|
|
PC Period: Percentage of Participants With Anti-BIIB092 Antibodies in Serum
|
1.9 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
1.0 percentage of participants
|
0 percentage of participants
|
Adverse Events
PC Period: Placebo
Serious events: 26 serious events
Other events: 121 other events
Deaths: 1 deaths
PC Period: BIIB092 125 mg/4 Week
Serious events: 6 serious events
Other events: 39 other events
Deaths: 1 deaths
PC Period: BIIB092 375 mg/12 Week
Serious events: 6 serious events
Other events: 38 other events
Deaths: 0 deaths
PC Period: BIIB092 600 mg/4 Week
Serious events: 13 serious events
Other events: 68 other events
Deaths: 0 deaths
PC Period: BIIB092 2000 mg/4 Week
Serious events: 25 serious events
Other events: 139 other events
Deaths: 1 deaths
LTE Period: BIIB092 125 mg/4 Week
Serious events: 5 serious events
Other events: 10 other events
Deaths: 2 deaths
LTE Period: BIIB092 375 mg/12 Week
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
LTE Period: BIIB092 600 mg/4 Week
Serious events: 9 serious events
Other events: 19 other events
Deaths: 1 deaths
LTE Period: BIIB092 2000 mg/4 Week - Early Start
Serious events: 10 serious events
Other events: 28 other events
Deaths: 1 deaths
LTE Period: BIIB092 2000 mg/4 Week - Late Start
Serious events: 13 serious events
Other events: 29 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
PC Period: Placebo
n=214 participants at risk
Participants received BIIB092-matching placebo, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 125 mg/4 Week
n=58 participants at risk
Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 375 mg/12 Week
n=58 participants at risk
Participants received BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 600 mg/4 Week
n=106 participants at risk
Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 2000 mg/4 Week
n=214 participants at risk
Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
LTE Period: BIIB092 125 mg/4 Week
n=45 participants at risk
Participants who received BIIB092, 125 mg, IV infusion during the PC period, continued to receive BIIB092, 125 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
|
LTE Period: BIIB092 375 mg/12 Week
n=49 participants at risk
Participants who received BIIB092, 375 mg, IV infusion during the PC period, continued to receive BIIB092, 375 mg, IV infusion once every 12 weeks from Week 80 to Week 155 during the LTE period.
|
LTE Period: BIIB092 600 mg/4 Week
n=89 participants at risk
Participants who received BIIB092, 600 mg, IV infusion during the PC period, continued to receive BIIB092, 600 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
|
LTE Period: BIIB092 2000 mg/4 Week - Early Start
n=168 participants at risk
Participants who received BIIB092, 2000 mg, IV infusion during the PC period, continued to receive BIIB092, 2000 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
|
LTE Period: BIIB092 2000 mg/4 Week - Late Start
n=165 participants at risk
Participants who received BIIB092-matching placebo, IV infusion during the PC period, received BIIB092, 2000 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Cardiac disorders
Angina pectoris
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Cardiac disorders
Atrial fibrillation
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.9%
2/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.61%
1/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.60%
1/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
2.2%
1/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Eye disorders
Cataract
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Eye disorders
Idiopathic orbital inflammation
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.1%
1/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.61%
1/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Gastrointestinal disorders
Dysphagia
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.94%
1/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.94%
1/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.61%
1/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
2.2%
1/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.61%
1/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.61%
1/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.1%
1/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Infections and infestations
Appendicitis
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.61%
1/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Infections and infestations
Atypical pneumonia
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.1%
1/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.61%
1/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Infections and infestations
Infection
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.94%
1/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.1%
1/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.60%
1/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Infections and infestations
Sepsis
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.1%
1/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.1%
1/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.61%
1/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.60%
1/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.1%
1/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Infections and infestations
Retroperitoneal abscess
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.61%
1/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Injury, poisoning and procedural complications
Fall
|
0.93%
2/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.94%
1/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
2.0%
1/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.8%
3/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.8%
3/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.94%
1/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
2.2%
1/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.61%
1/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.61%
1/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.94%
1/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.60%
1/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.61%
1/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.60%
1/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
2.0%
1/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.60%
1/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.60%
1/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.9%
2/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.1%
1/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.61%
1/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.60%
1/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma stage III
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penile squamous cell carcinoma
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.61%
1/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.61%
1/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
2.2%
1/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Nervous system disorders
Epilepsy
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.1%
1/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Nervous system disorders
Seizure
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.94%
1/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.1%
1/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.60%
1/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Nervous system disorders
Syncope
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.94%
1/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.93%
2/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.60%
1/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.94%
1/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
2.2%
1/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.61%
1/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Product Issues
Device dislocation
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
2.0%
1/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Psychiatric disorders
Delusion
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.61%
1/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.60%
1/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Psychiatric disorders
Depression
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.94%
1/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.93%
2/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.61%
1/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
2.2%
1/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.60%
1/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.94%
1/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
2.2%
1/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
Other adverse events
| Measure |
PC Period: Placebo
n=214 participants at risk
Participants received BIIB092-matching placebo, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 125 mg/4 Week
n=58 participants at risk
Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 375 mg/12 Week
n=58 participants at risk
Participants received BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 600 mg/4 Week
n=106 participants at risk
Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
PC Period: BIIB092 2000 mg/4 Week
n=214 participants at risk
Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.
|
LTE Period: BIIB092 125 mg/4 Week
n=45 participants at risk
Participants who received BIIB092, 125 mg, IV infusion during the PC period, continued to receive BIIB092, 125 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
|
LTE Period: BIIB092 375 mg/12 Week
n=49 participants at risk
Participants who received BIIB092, 375 mg, IV infusion during the PC period, continued to receive BIIB092, 375 mg, IV infusion once every 12 weeks from Week 80 to Week 155 during the LTE period.
|
LTE Period: BIIB092 600 mg/4 Week
n=89 participants at risk
Participants who received BIIB092, 600 mg, IV infusion during the PC period, continued to receive BIIB092, 600 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
|
LTE Period: BIIB092 2000 mg/4 Week - Early Start
n=168 participants at risk
Participants who received BIIB092, 2000 mg, IV infusion during the PC period, continued to receive BIIB092, 2000 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
|
LTE Period: BIIB092 2000 mg/4 Week - Late Start
n=165 participants at risk
Participants who received BIIB092-matching placebo, IV infusion during the PC period, received BIIB092, 2000 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
3.7%
8/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
8.6%
5/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.9%
2/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
2.8%
6/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
12/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
19.0%
11/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.2%
3/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.7%
6/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.1%
11/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Gastrointestinal disorders
Nausea
|
6.1%
13/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
6.9%
4/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
3.4%
2/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.7%
6/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.1%
11/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
General disorders
Fatigue
|
3.3%
7/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
6.9%
4/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
7.5%
8/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.6%
12/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Infections and infestations
Nasopharyngitis
|
10.3%
22/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
6.9%
4/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
10.3%
6/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
8.5%
9/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
11.2%
24/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Infections and infestations
Sinusitis
|
0.93%
2/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.2%
3/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.94%
1/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
3.3%
7/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.0%
15/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
8.6%
5/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.2%
3/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.7%
6/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
7.0%
15/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Infections and infestations
Urinary tract infection
|
6.1%
13/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
8.6%
5/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.2%
3/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
7.5%
8/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
9.3%
20/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Infections and infestations
COVID-19
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
4.4%
2/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
2.0%
1/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
10.1%
9/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.2%
2/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.8%
3/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Injury, poisoning and procedural complications
Fall
|
10.7%
23/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
10.3%
6/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
19.0%
11/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
17.9%
19/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
14.0%
30/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
11.1%
5/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
14.3%
7/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
6.7%
6/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
8.3%
14/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
9.1%
15/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.8%
6/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
7.5%
8/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
2.3%
5/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.2%
3/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.94%
1/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Investigations
Weight decreased
|
1.9%
4/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
3.4%
2/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.2%
3/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
2.8%
3/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
2.3%
5/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.93%
2/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.2%
3/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.93%
2/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
14/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
10.3%
6/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
12.1%
7/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
8.5%
9/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
8.9%
19/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
6.1%
3/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
4.5%
4/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
3.6%
6/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.8%
3/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.5%
16/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
8.6%
5/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.2%
3/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
8.5%
9/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
6.1%
13/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
6.7%
3/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
2.2%
2/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
3.0%
5/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
3.0%
5/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.4%
3/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.2%
3/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
2.8%
3/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
3.3%
7/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.93%
2/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.2%
3/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.9%
2/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
2.3%
5/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Nervous system disorders
Dizziness
|
6.1%
13/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
8.6%
5/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
3.4%
2/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
8.5%
9/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.1%
11/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Nervous system disorders
Headache
|
9.3%
20/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
10.3%
6/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
10.4%
11/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
10.3%
22/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
2.2%
1/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
6.1%
3/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
4.5%
4/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.8%
3/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
3.6%
6/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Psychiatric disorders
Anxiety
|
5.1%
11/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
6.9%
4/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
3.4%
2/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
2.8%
3/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
7.0%
15/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Psychiatric disorders
Confusional state
|
2.3%
5/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
6.9%
4/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
3.8%
4/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.93%
2/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Psychiatric disorders
Depression
|
6.1%
13/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
6.9%
4/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
3.4%
2/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
3.8%
4/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.1%
11/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Psychiatric disorders
Disorientation
|
0.93%
2/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.2%
3/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.94%
1/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Psychiatric disorders
Irritability
|
0.93%
2/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.2%
3/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
3.4%
2/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
2.8%
3/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.4%
3/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.2%
3/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.4%
3/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
5/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.2%
3/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
6.6%
7/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
7.5%
16/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.47%
1/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
1.7%
1/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.2%
3/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.94%
1/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.93%
2/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
|
Vascular disorders
Hypertension
|
6.5%
14/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
8.6%
5/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.2%
3/58 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
5.7%
6/106 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
6.1%
13/214 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/45 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/49 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/89 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/168 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
0.00%
0/165 • From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)
The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for non-commercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER