Trial Outcomes & Findings for A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis (NCT NCT03737851)
NCT ID: NCT03737851
Last Updated: 2023-12-22
Results Overview
The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND). Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1. The ORS is the sum of these scores for the EDSS: Timed 25-Foot Walk, 9-Hole Peg Test-dominant, and 9-Hole Peg Test-nondominant and ranges from -4 to + 4.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
208 participants
Primary outcome timeframe
Week 52
Results posted on
2023-12-22
Participant Flow
A total of 208 subjects from 44 sites in the United States \& Canada were enrolled into the study and were randomized: 208 subjects received at least 1 dose of study drug. Of the 208 subjects who received study drug, 182 completed treatment.
Participant milestones
| Measure |
Placebo
Participants randomized to receive double-blind placebo by intravenous infusion.
placebo: solution for infusion
|
Elezanumab Dose 1
Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.
elezanumab: solution for infusion
|
Elezanumab Dose 2
Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.
elezanumab: solution for infusion
|
|---|---|---|---|
|
Overall Study
STARTED
|
70
|
69
|
69
|
|
Overall Study
COMPLETED
|
62
|
63
|
57
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Placebo
n=70 Participants
Participants randomized to receive double-blind placebo by intravenous infusion.
placebo: solution for infusion
|
Elezanumab Dose 1
n=69 Participants
Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.
elezanumab: solution for infusion
|
Elezanumab Dose 2
n=69 Participants
Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.
elezanumab: solution for infusion
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
208 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
188 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
60 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
184 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=5 Participants
|
64 participants
n=7 Participants
|
65 participants
n=5 Participants
|
198 participants
n=4 Participants
|
|
Type of Multiple Sclerosis (MS)
relapsing remitting MS (RRMS)
|
66 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
199 Participants
n=4 Participants
|
|
Type of Multiple Sclerosis (MS)
relapsing secondary-progressive MS (rSPMS)
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: The Modified Intent-to-Treat (mITT) Analysis Set consists of all randomized subjects who received at least 1 dose of study drug. Subjects were grouped according to treatment as randomized.
The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND). Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1. The ORS is the sum of these scores for the EDSS: Timed 25-Foot Walk, 9-Hole Peg Test-dominant, and 9-Hole Peg Test-nondominant and ranges from -4 to + 4.
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants randomized to receive double-blind placebo by intravenous infusion.
placebo: solution for infusion
|
Elezanumab Dose 1
n=61 Participants
Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.
elezanumab: solution for infusion
|
Elezanumab Dose 2
n=55 Participants
Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.
elezanumab: solution for infusion
|
|---|---|---|---|
|
Mean Overall Response Score (ORS) at Week 52
|
0.04 score on a scale
Standard Error 0.175
|
-0.17 score on a scale
Standard Error 0.179
|
-0.17 score on a scale
Standard Error 0.177
|
SECONDARY outcome
Timeframe: Week 52Population: The Modified Intent-to-Treat (mITT) Analysis Set consists of all randomized subjects who received at least 1 dose of study drug. Subjects were grouped according to treatment as randomized.
Disability improvement response rate is assessed based on the Expanded Disability Status Scale Plus (EDSS+). EDSS+ is comprised of EDSS, Timed 25-Foot Walk (T25FW) and 9-Hole Peg Tests (9HPT).
Outcome measures
| Measure |
Placebo
n=70 Participants
Participants randomized to receive double-blind placebo by intravenous infusion.
placebo: solution for infusion
|
Elezanumab Dose 1
n=69 Participants
Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.
elezanumab: solution for infusion
|
Elezanumab Dose 2
n=69 Participants
Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.
elezanumab: solution for infusion
|
|---|---|---|---|
|
Disability Improvement Response Rate
|
18 Participants
|
20 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: The Modified Intent-to-Treat (mITT) Analysis Set consists of all randomized subjects who received at least 1 dose of study drug. Subjects were grouped according to treatment as randomized.
The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND). Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1. The ORS is the sum of these scores for the EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant and 9-Hole Peg Test-non-dominant and ranges from -4 to + 4.
Outcome measures
| Measure |
Placebo
n=63 Participants
Participants randomized to receive double-blind placebo by intravenous infusion.
placebo: solution for infusion
|
Elezanumab Dose 1
n=65 Participants
Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.
elezanumab: solution for infusion
|
Elezanumab Dose 2
n=68 Participants
Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.
elezanumab: solution for infusion
|
|---|---|---|---|
|
Overall Response Score (ORS)
|
0.05 score on a scale
Standard Error 0.153
|
-0.06 score on a scale
Standard Error 0.159
|
0.12 score on a scale
Standard Error 0.150
|
SECONDARY outcome
Timeframe: Week 24Population: The Modified Intent-to-Treat (mITT) Analysis Set consists of all randomized subjects who received at least 1 dose of study drug. Subjects were grouped according to treatment as randomized.
The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND). Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1. The ORS is the sum of these scores for the EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant and 9-Hole Peg Test-non-dominant and ranges from -4 to + 4.
Outcome measures
| Measure |
Placebo
n=60 Participants
Participants randomized to receive double-blind placebo by intravenous infusion.
placebo: solution for infusion
|
Elezanumab Dose 1
n=57 Participants
Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.
elezanumab: solution for infusion
|
Elezanumab Dose 2
n=59 Participants
Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.
elezanumab: solution for infusion
|
|---|---|---|---|
|
Overall Response Score (ORS)
|
-0.04 score on a scale
Standard Error 0.167
|
-0.13 score on a scale
Standard Error 0.175
|
-0.06 score on a scale
Standard Error 0.168
|
SECONDARY outcome
Timeframe: Week 36Population: The Modified Intent-to-Treat (mITT) Analysis Set consists of all randomized subjects who received at least 1 dose of study drug. Subjects were grouped according to treatment as randomized.
The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND). Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1. The ORS is the sum of these scores for the EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant and 9-Hole Peg Test-non-dominant and ranges from -4 to + 4.
Outcome measures
| Measure |
Placebo
n=55 Participants
Participants randomized to receive double-blind placebo by intravenous infusion.
placebo: solution for infusion
|
Elezanumab Dose 1
n=58 Participants
Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.
elezanumab: solution for infusion
|
Elezanumab Dose 2
n=51 Participants
Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.
elezanumab: solution for infusion
|
|---|---|---|---|
|
Overall Response Score (ORS)
|
0.09 score on a scale
Standard Deviation 0.180
|
-0.10 score on a scale
Standard Deviation 0.184
|
-0.17 score on a scale
Standard Deviation 0.183
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 52 other events
Deaths: 1 deaths
Elezanumab Dose 1
Serious events: 7 serious events
Other events: 48 other events
Deaths: 0 deaths
Elezanumab Dose 2
Serious events: 4 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=70 participants at risk
Participants randomized to receive double-blind placebo by intravenous infusion.
placebo: solution for infusion
|
Elezanumab Dose 1
n=69 participants at risk
Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.
elezanumab: solution for infusion
|
Elezanumab Dose 2
n=69 participants at risk
Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.
elezanumab: solution for infusion
|
|---|---|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
1.4%
1/70 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
DIVERTICULUM INTESTINAL
|
0.00%
0/70 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
1.4%
1/69 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.00%
0/70 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
1.4%
1/69 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.00%
0/70 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
1.4%
1/69 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
General disorders
ASTHENIA
|
1.4%
1/70 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
General disorders
PYREXIA
|
1.4%
1/70 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/70 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
1.4%
1/69 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Infections and infestations
APPENDICITIS
|
1.4%
1/70 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
1.4%
1/69 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Infections and infestations
COVID-19
|
1.4%
1/70 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
1.4%
1/70 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/70 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
1.4%
1/69 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/70 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
1.4%
1/69 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
FRACTURE DISPLACEMENT
|
0.00%
0/70 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
1.4%
1/69 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
SKULL FRACTURED BASE
|
0.00%
0/70 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
1.4%
1/69 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Investigations
MYOCARDIAL STRAIN
|
1.4%
1/70 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
1.4%
1/70 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Nervous system disorders
MYELOPATHY
|
0.00%
0/70 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
1.4%
1/69 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/70 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
1.4%
1/69 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Nervous system disorders
TRIGEMINAL NEURALGIA
|
1.4%
1/70 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Nervous system disorders
UHTHOFF'S PHENOMENON
|
0.00%
0/70 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
1.4%
1/69 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.00%
0/70 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
1.4%
1/69 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
1.4%
1/70 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
2.9%
2/70 • Number of events 2 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
1.4%
1/70 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=70 participants at risk
Participants randomized to receive double-blind placebo by intravenous infusion.
placebo: solution for infusion
|
Elezanumab Dose 1
n=69 participants at risk
Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion.
elezanumab: solution for infusion
|
Elezanumab Dose 2
n=69 participants at risk
Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion.
elezanumab: solution for infusion
|
|---|---|---|---|
|
Ear and labyrinth disorders
VERTIGO
|
2.9%
2/70 • Number of events 2 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
2.9%
2/69 • Number of events 2 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
5.8%
4/69 • Number of events 4 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
8.6%
6/70 • Number of events 6 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
CONSTIPATION
|
8.6%
6/70 • Number of events 6 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
7.2%
5/69 • Number of events 5 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
8.7%
6/69 • Number of events 6 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
DIARRHOEA
|
7.1%
5/70 • Number of events 5 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
1.4%
1/69 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
2.9%
2/69 • Number of events 3 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
2.9%
2/70 • Number of events 2 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
4.3%
3/69 • Number of events 3 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
5.8%
4/69 • Number of events 4 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
5.7%
4/70 • Number of events 4 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
4.3%
3/69 • Number of events 3 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
8.7%
6/69 • Number of events 6 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/70 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
0.00%
0/69 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
7.2%
5/69 • Number of events 5 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
General disorders
FATIGUE
|
14.3%
10/70 • Number of events 16 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
5.8%
4/69 • Number of events 4 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
11.6%
8/69 • Number of events 10 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
General disorders
PAIN
|
7.1%
5/70 • Number of events 5 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
1.4%
1/69 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
4.3%
3/69 • Number of events 4 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Infections and infestations
COVID-19
|
5.7%
4/70 • Number of events 4 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
4.3%
3/69 • Number of events 3 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
8.7%
6/69 • Number of events 6 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Infections and infestations
INFLUENZA
|
2.9%
2/70 • Number of events 2 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
4.3%
3/69 • Number of events 3 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
7.2%
5/69 • Number of events 5 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.7%
4/70 • Number of events 4 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
7.2%
5/69 • Number of events 5 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
7.2%
5/69 • Number of events 5 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Infections and infestations
SINUSITIS
|
4.3%
3/70 • Number of events 4 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
2.9%
2/69 • Number of events 2 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
5.8%
4/69 • Number of events 4 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
4.3%
3/70 • Number of events 3 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
2.9%
2/69 • Number of events 2 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
8.7%
6/69 • Number of events 7 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
14.3%
10/70 • Number of events 19 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
13.0%
9/69 • Number of events 15 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
14.5%
10/69 • Number of events 12 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
FALL
|
17.1%
12/70 • Number of events 14 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
15.9%
11/69 • Number of events 16 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
14.5%
10/69 • Number of events 13 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
8.6%
6/70 • Number of events 23 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
7.2%
5/69 • Number of events 9 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
8.7%
6/69 • Number of events 12 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.00%
0/70 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
4.3%
3/69 • Number of events 3 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
7.2%
5/69 • Number of events 5 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.1%
5/70 • Number of events 6 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
11.6%
8/69 • Number of events 9 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
5.8%
4/69 • Number of events 4 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
7.1%
5/70 • Number of events 6 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
1.4%
1/69 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
5.8%
4/69 • Number of events 4 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
5.7%
4/70 • Number of events 5 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
4.3%
3/69 • Number of events 3 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
2.9%
2/69 • Number of events 3 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Nervous system disorders
DIZZINESS
|
4.3%
3/70 • Number of events 3 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
4.3%
3/69 • Number of events 5 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
5.8%
4/69 • Number of events 5 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Nervous system disorders
HEADACHE
|
11.4%
8/70 • Number of events 13 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
13.0%
9/69 • Number of events 13 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
7.2%
5/69 • Number of events 6 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Nervous system disorders
MIGRAINE
|
5.7%
4/70 • Number of events 4 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
2.9%
2/69 • Number of events 2 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
4.3%
3/69 • Number of events 3 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Nervous system disorders
MULTIPLE SCLEROSIS RELAPSE
|
7.1%
5/70 • Number of events 6 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
8.7%
6/69 • Number of events 8 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
8.7%
6/69 • Number of events 6 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Nervous system disorders
MUSCLE SPASTICITY
|
1.4%
1/70 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
7.2%
5/69 • Number of events 5 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
7.2%
5/69 • Number of events 5 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Psychiatric disorders
ANXIETY
|
1.4%
1/70 • Number of events 1 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
4.3%
3/69 • Number of events 3 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
5.8%
4/69 • Number of events 4 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
|
Psychiatric disorders
INSOMNIA
|
2.9%
2/70 • Number of events 2 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
7.2%
5/69 • Number of events 5 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
2.9%
2/69 • Number of events 2 • Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER