Trial Outcomes & Findings for A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis (NCT NCT03737812)
NCT ID: NCT03737812
Last Updated: 2023-12-21
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
123 participants
Primary outcome timeframe
Week 52
Results posted on
2023-12-21
Participant Flow
A total of 123 subjects from 35 sites in the United States \& Canada were enrolled into the study, were randomized, and received at least 1 dose of study drug. Of these, 108 completed treatment
Participant milestones
| Measure |
Placebo
Participants randomized to receive placebo by intravenous infusion.
placebo: solution for infusion
|
Elezanumab 400mg Dose
Participants randomized to receive 400mg of elezanumab by intravenous infusion.
elezanumab: solution for infusion
|
Elezanumab 1800 mg Dose
Participants randomized to receive 1800mg of elezanumab by intravenous infusion.
elezanumab: solution for infusion
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
40
|
40
|
|
Overall Study
COMPLETED
|
38
|
34
|
36
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Participants randomized to receive placebo by intravenous infusion.
placebo: solution for infusion
|
Elezanumab 400mg Dose
Participants randomized to receive 400mg of elezanumab by intravenous infusion.
elezanumab: solution for infusion
|
Elezanumab 1800 mg Dose
Participants randomized to receive 1800mg of elezanumab by intravenous infusion.
elezanumab: solution for infusion
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
|
Overall Study
Sponsor Discontinued the Study
|
4
|
3
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
COVID -19 Logistical Restrictions
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Placebo
n=43 Participants
Participants randomized to receive placebo by intravenous infusion.
placebo: solution for infusion
|
Elezanumab 400mg Dose
n=40 Participants
Participants randomized to receive 400mg of elezanumab by intravenous infusion.
elezanumab: solution for infusion
|
Elezanumab 1800 mg Dose
n=40 Participants
Participants randomized to receive 1800mg of elezanumab by intravenous infusion.
elezanumab: solution for infusion
|
Total
n=123 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
|
43 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
118 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 (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (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
|
|
Region of Enrollment
Canada
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
9 participants
n=5 Participants
|
32 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
31 participants
n=5 Participants
|
91 participants
n=4 Participants
|
|
Type of MS
Primary progressive MS (PPMS)
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Type of MS
Non-relapsing secondary progressive multiple sclerosis (nrSPMS)
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
64 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.
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=36 Participants
Participants randomized to receive placebo by intravenous infusion.
placebo: solution for infusion
|
Elezanumab 400mg Dose
n=31 Participants
Participants randomized to receive 400mg of elezanumab by intravenous infusion.
elezanumab: solution for infusion
|
Elezanumab 1800 mg Dose
n=34 Participants
Participants randomized to receive 1800mg of elezanumab by intravenous infusion.
elezanumab: solution for infusion
|
|---|---|---|---|
|
Mean Overall Response Score (ORS)
|
-0.74 score on a scale
Standard Error 0.167
|
-0.75 score on a scale
Standard Error 0.176
|
-0.64 score on a scale
Standard Error 0.170
|
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.
Disability improvement response rate is assessed based on the Expanded Disability Status Scale Plus (EDSS+). EDSS+ is comprised of Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW) and 9-Hole Peg Tests (9HPT).
Outcome measures
| Measure |
Placebo
n=43 Participants
Participants randomized to receive placebo by intravenous infusion.
placebo: solution for infusion
|
Elezanumab 400mg Dose
n=40 Participants
Participants randomized to receive 400mg of elezanumab by intravenous infusion.
elezanumab: solution for infusion
|
Elezanumab 1800 mg Dose
n=40 Participants
Participants randomized to receive 1800mg of elezanumab by intravenous infusion.
elezanumab: solution for infusion
|
|---|---|---|---|
|
Disability Improvement Response Rate
|
3 Participants
|
7 Participants
|
9 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.
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).
Outcome measures
| Measure |
Placebo
n=38 Participants
Participants randomized to receive placebo by intravenous infusion.
placebo: solution for infusion
|
Elezanumab 400mg Dose
n=35 Participants
Participants randomized to receive 400mg of elezanumab by intravenous infusion.
elezanumab: solution for infusion
|
Elezanumab 1800 mg Dose
n=34 Participants
Participants randomized to receive 1800mg of elezanumab by intravenous infusion.
elezanumab: solution for infusion
|
|---|---|---|---|
|
Overall Response Score (ORS)
|
-0.47 score on a scale
Standard Error 0.134
|
0.00 score on a scale
Standard Error 0.136
|
-0.21 score on a scale
Standard Error 0.139
|
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.
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=36 Participants
Participants randomized to receive placebo by intravenous infusion.
placebo: solution for infusion
|
Elezanumab 400mg Dose
n=28 Participants
Participants randomized to receive 400mg of elezanumab by intravenous infusion.
elezanumab: solution for infusion
|
Elezanumab 1800 mg Dose
n=31 Participants
Participants randomized to receive 1800mg of elezanumab by intravenous infusion.
elezanumab: solution for infusion
|
|---|---|---|---|
|
Overall Response Score (ORS)
|
-0.28 score on a scale
Standard Error 0.176
|
-0.27 score on a scale
Standard Error 0.194
|
-0.53 score on a scale
Standard Error 0.188
|
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.
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=35 Participants
Participants randomized to receive placebo by intravenous infusion.
placebo: solution for infusion
|
Elezanumab 400mg Dose
n=26 Participants
Participants randomized to receive 400mg of elezanumab by intravenous infusion.
elezanumab: solution for infusion
|
Elezanumab 1800 mg Dose
n=30 Participants
Participants randomized to receive 1800mg of elezanumab by intravenous infusion.
elezanumab: solution for infusion
|
|---|---|---|---|
|
Overall Response Score (ORS)
|
-0.45 score on a scale
Standard Error 0.159
|
-0.48 score on a scale
Standard Error 0.178
|
-0.52 score on a scale
Standard Error 0.169
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 34 other events
Deaths: 1 deaths
Elezanumab 400mg Dose
Serious events: 5 serious events
Other events: 29 other events
Deaths: 1 deaths
Elezanumab 1800 mg Dose
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=43 participants at risk
Participants randomized to receive placebo by intravenous infusion.
Placebo: solution for infusion
|
Elezanumab 400mg Dose
n=40 participants at risk
Participants randomized to receive 400mg of elezanumab by intravenous infusion.
Elezanumab: solution for infusion
|
Elezanumab 1800 mg Dose
n=40 participants at risk
Participants randomized to receive 1800mg of elezanumab by intravenous infusion.
Elezanumab: solution for infusion
|
|---|---|---|---|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/43 • 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.
|
2.5%
1/40 • 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%
0/40 • 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.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.00%
0/43 • 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%
0/40 • 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.
|
2.5%
1/40 • 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.
|
|
Gastrointestinal disorders
INTESTINAL PSEUDO-OBSTRUCTION
|
0.00%
0/43 • 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.
|
2.5%
1/40 • 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%
0/40 • 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
CHILLS
|
0.00%
0/43 • 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%
0/40 • 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.
|
2.5%
1/40 • 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
DEATH
|
2.3%
1/43 • 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%
0/40 • 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%
0/40 • 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
|
0.00%
0/43 • 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%
0/40 • 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.
|
2.5%
1/40 • 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.
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.00%
0/43 • 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.
|
2.5%
1/40 • 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%
0/40 • 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
DIVERTICULITIS
|
0.00%
0/43 • 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%
0/40 • 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.
|
2.5%
1/40 • 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.
|
|
Infections and infestations
PNEUMONIA
|
2.3%
1/43 • 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%
0/40 • 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%
0/40 • 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
SEPSIS
|
0.00%
0/43 • 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.
|
2.5%
1/40 • 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%
0/40 • 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%
0/43 • 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.
|
2.5%
1/40 • 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%
0/40 • 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
|
0.00%
0/43 • 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.
|
2.5%
1/40 • 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%
0/40 • 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
PATELLA FRACTURE
|
0.00%
0/43 • 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.
|
2.5%
1/40 • 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%
0/40 • 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
DIABETIC KETOACIDOSIS
|
0.00%
0/43 • 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.
|
2.5%
1/40 • 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%
0/40 • 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
|
0.00%
0/43 • 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%
0/40 • 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.
|
2.5%
1/40 • 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.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
2.3%
1/43 • 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%
0/40 • 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%
0/40 • 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
|
0.00%
0/43 • 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.
|
2.5%
1/40 • 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%
0/40 • 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
SYNCOPE
|
0.00%
0/43 • 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.
|
2.5%
1/40 • 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%
0/40 • 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%
0/43 • 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.
|
2.5%
1/40 • 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%
0/40 • 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
RESPIRATORY FAILURE
|
0.00%
0/43 • 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.
|
2.5%
1/40 • 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%
0/40 • 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=43 participants at risk
Participants randomized to receive placebo by intravenous infusion.
Placebo: solution for infusion
|
Elezanumab 400mg Dose
n=40 participants at risk
Participants randomized to receive 400mg of elezanumab by intravenous infusion.
Elezanumab: solution for infusion
|
Elezanumab 1800 mg Dose
n=40 participants at risk
Participants randomized to receive 1800mg of elezanumab by intravenous infusion.
Elezanumab: solution for infusion
|
|---|---|---|---|
|
Ear and labyrinth disorders
VERTIGO
|
7.0%
3/43 • 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.
|
7.5%
3/40 • 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.
|
2.5%
1/40 • 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.
|
|
Gastrointestinal disorders
CONSTIPATION
|
4.7%
2/43 • 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.
|
2.5%
1/40 • 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.
|
5.0%
2/40 • 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.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
7.0%
3/43 • 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.
|
2.5%
1/40 • 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.
|
2.5%
1/40 • 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.
|
|
Gastrointestinal disorders
NAUSEA
|
4.7%
2/43 • 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.
|
5.0%
2/40 • 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.
|
5.0%
2/40 • 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.
|
|
Gastrointestinal disorders
VOMITING
|
2.3%
1/43 • 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.
|
2.5%
1/40 • 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.
|
5.0%
2/40 • 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.
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/43 • 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.
|
5.0%
2/40 • 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%
0/40 • 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
|
9.3%
4/43 • 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.
|
15.0%
6/40 • 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.
|
15.0%
6/40 • 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.
|
|
General disorders
PAIN
|
0.00%
0/43 • 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.
|
5.0%
2/40 • 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.
|
7.5%
3/40 • 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.
|
|
General disorders
PYREXIA
|
2.3%
1/43 • 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.
|
2.5%
1/40 • 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.
|
5.0%
2/40 • 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.
|
|
Infections and infestations
COVID-19
|
9.3%
4/43 • 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.
|
5.0%
2/40 • 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.
|
2.5%
1/40 • 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.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/43 • 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.
|
5.0%
2/40 • 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.
|
2.5%
1/40 • 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.
|
|
Infections and infestations
NASOPHARYNGITIS
|
7.0%
3/43 • 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.
|
10.0%
4/40 • 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.
|
5.0%
2/40 • 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.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/43 • 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.
|
5.0%
2/40 • 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.
|
2.5%
1/40 • 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.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
2.3%
1/43 • 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.
|
5.0%
2/40 • 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.
|
7.5%
3/40 • 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
|
16.3%
7/43 • 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.
|
20.0%
8/40 • 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.
|
22.5%
9/40 • 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.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/43 • 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%
0/40 • 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.
|
5.0%
2/40 • 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.
|
|
Injury, poisoning and procedural complications
FALL
|
14.0%
6/43 • 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.
|
10.0%
4/40 • 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.
|
22.5%
9/40 • 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.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
11.6%
5/43 • 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.
|
5.0%
2/40 • 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.
|
20.0%
8/40 • 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.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.0%
3/43 • 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.
|
10.0%
4/40 • 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.
|
5.0%
2/40 • 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.
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
7.0%
3/43 • 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.
|
2.5%
1/40 • 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.
|
2.5%
1/40 • 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.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
7.0%
3/43 • 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.
|
5.0%
2/40 • 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.
|
2.5%
1/40 • 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.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
7.0%
3/43 • 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.
|
12.5%
5/40 • 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.
|
10.0%
4/40 • 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
PAIN IN EXTREMITY
|
11.6%
5/43 • 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.
|
7.5%
3/40 • 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.
|
2.5%
1/40 • 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
DIZZINESS
|
7.0%
3/43 • 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.
|
0.00%
0/40 • 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%
0/40 • 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
|
16.3%
7/43 • Number of events 20 • 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.
|
12.5%
5/40 • 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.
|
10.0%
4/40 • 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
HYPOAESTHESIA
|
2.3%
1/43 • 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.
|
7.5%
3/40 • 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.
|
0.00%
0/40 • 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
|
4.7%
2/43 • 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.
|
2.5%
1/40 • 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.
|
7.5%
3/40 • 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
MUSCLE SPASTICITY
|
4.7%
2/43 • 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.
|
2.5%
1/40 • 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.
|
5.0%
2/40 • 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.
|
|
Nervous system disorders
NEURALGIA
|
7.0%
3/43 • 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.
|
0.00%
0/40 • 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%
0/40 • 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
PARAESTHESIA
|
0.00%
0/43 • 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.
|
5.0%
2/40 • 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.
|
5.0%
2/40 • 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.
|
|
Psychiatric disorders
DEPRESSION
|
4.7%
2/43 • 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.
|
5.0%
2/40 • 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.
|
2.5%
1/40 • 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.
|
|
Psychiatric disorders
INSOMNIA
|
9.3%
4/43 • 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.
|
2.5%
1/40 • 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.
|
2.5%
1/40 • 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.
|
|
Psychiatric disorders
SLEEP DISORDER
|
0.00%
0/43 • 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.
|
2.5%
1/40 • 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.
|
5.0%
2/40 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/43 • 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.
|
2.5%
1/40 • 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.
|
5.0%
2/40 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/43 • 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.
|
2.5%
1/40 • 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.
|
5.0%
2/40 • 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.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
2.3%
1/43 • 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.
|
7.5%
3/40 • 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.
|
0.00%
0/40 • 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
HOT FLUSH
|
0.00%
0/43 • 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.
|
10.0%
4/40 • 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.
|
0.00%
0/40 • 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