Trial Outcomes & Findings for Efficacy and Safety of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine (NCT NCT02638103)
NCT ID: NCT02638103
Last Updated: 2021-11-09
Results Overview
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE was defined as inability to carry out usual activities. Treatment-related AEs were defined as AEs with possible, probable, definite, or missing relationship to study drug. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1890 participants
Primary outcome timeframe
Baseline (Day 0) up to follow-up visit (Day 533)
Results posted on
2021-11-09
Participant Flow
Participants with chronic or episodic migraine (CM or EM) who completed the pivotal efficacy studies of fremanezumab (TV48125-CNS-30049 \[NCT02621931\] and TV48125-CNS-30050 \[NCT02629861\]) and agreed to participate in this study; and new participants meeting eligibility criteria (not rolling over from pivotal studies), were enrolled in this study.
A total of 1890 participants were enrolled, including 917 participants with CM rolled over from Study TV48125-CNS-30049, 661 participants with EM rolled over from Study TV48125-CNS-30050, and 312 newly enrolled participants (193 with CM and 119 with EM).
Participant milestones
| Measure |
TEV-48125 225 mg Monthly: New/Placebo Rollover Participants
Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab (TEV-48125) 675 milligrams (mg) subcutaneously (SC) as loading dose (3 injections of fremanezumab 225 mg/1.5 milliliters \[mL\] on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 225 mg Monthly: Active Rollover Participants
Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants
Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: Active Rollover Participants
Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
419
|
526
|
420
|
525
|
|
Overall Study
Safety Analysis Set
|
418
|
526
|
419
|
525
|
|
Overall Study
Full Analysis Set (FAS)
|
416
|
520
|
419
|
523
|
|
Overall Study
COMPLETED
|
313
|
408
|
335
|
383
|
|
Overall Study
NOT COMPLETED
|
106
|
118
|
85
|
142
|
Reasons for withdrawal
| Measure |
TEV-48125 225 mg Monthly: New/Placebo Rollover Participants
Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab (TEV-48125) 675 milligrams (mg) subcutaneously (SC) as loading dose (3 injections of fremanezumab 225 mg/1.5 milliliters \[mL\] on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 225 mg Monthly: Active Rollover Participants
Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants
Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: Active Rollover Participants
Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
13
|
12
|
19
|
12
|
|
Overall Study
Withdrawal by Subject
|
43
|
53
|
30
|
61
|
|
Overall Study
Protocol Violation
|
1
|
2
|
1
|
4
|
|
Overall Study
Pregnancy
|
2
|
3
|
0
|
1
|
|
Overall Study
Non-compliance to Study Procedures
|
2
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
26
|
33
|
20
|
37
|
|
Overall Study
Lack of Efficacy
|
14
|
10
|
12
|
22
|
|
Overall Study
Other than specified
|
5
|
4
|
2
|
4
|
Baseline Characteristics
Efficacy and Safety of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine
Baseline characteristics by cohort
| Measure |
TEV-48125 225 mg Monthly: New/Placebo Rollover Participants
n=419 Participants
Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 225 mg Monthly: Active Rollover Participants
n=526 Participants
Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants
n=420 Participants
Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: Active Rollover Participants
n=525 Participants
Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
Total
n=1890 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.1 years
STANDARD_DEVIATION 12.09 • n=5 Participants
|
42.9 years
STANDARD_DEVIATION 11.97 • n=7 Participants
|
44.0 years
STANDARD_DEVIATION 11.67 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 11.73 • n=4 Participants
|
43.5 years
STANDARD_DEVIATION 11.87 • n=21 Participants
|
|
Sex: Female, Male
Female
|
365 Participants
n=5 Participants
|
454 Participants
n=7 Participants
|
369 Participants
n=5 Participants
|
457 Participants
n=4 Participants
|
1645 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
245 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
146 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
387 Participants
n=5 Participants
|
481 Participants
n=7 Participants
|
386 Participants
n=5 Participants
|
484 Participants
n=4 Participants
|
1738 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
351 Participants
n=5 Participants
|
424 Participants
n=7 Participants
|
343 Participants
n=5 Participants
|
412 Participants
n=4 Participants
|
1530 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
32 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
148 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
29 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
191 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Number of Migraine Days
|
13.9 days
STANDARD_DEVIATION 5.99 • n=5 Participants
|
13.1 days
STANDARD_DEVIATION 5.49 • n=7 Participants
|
13.6 days
STANDARD_DEVIATION 5.86 • n=5 Participants
|
13.2 days
STANDARD_DEVIATION 5.26 • n=4 Participants
|
13.4 days
STANDARD_DEVIATION 5.63 • n=21 Participants
|
|
Number of Headache Days of Any Severity
|
13.6 days
STANDARD_DEVIATION 6.68 • n=5 Participants
|
12.7 days
STANDARD_DEVIATION 6.20 • n=7 Participants
|
13.2 days
STANDARD_DEVIATION 6.32 • n=5 Participants
|
12.9 days
STANDARD_DEVIATION 6.02 • n=4 Participants
|
13.1 days
STANDARD_DEVIATION 6.29 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) up to follow-up visit (Day 533)Population: Safety population included all participants who received at least 1 dose of fremanezumab.
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE was defined as inability to carry out usual activities. Treatment-related AEs were defined as AEs with possible, probable, definite, or missing relationship to study drug. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
TEV-48125 225 mg Monthly: Active Rollover Participants
n=526 Participants
Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants
n=419 Participants
Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: Active Rollover Participants
n=525 Participants
Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover CM Participants
n=418 Participants
Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: Active Rollover EM Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675 mg Quarterly: Active Rollover EM Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any AEs
|
456 Participants
|
365 Participants
|
426 Participants
|
365 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Severe AEs
|
51 Participants
|
45 Participants
|
50 Participants
|
47 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Treatment-related AEs
|
288 Participants
|
242 Participants
|
270 Participants
|
263 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Serious AEs
|
29 Participants
|
36 Participants
|
23 Participants
|
27 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
AEs leading to discontinuation from study
|
18 Participants
|
22 Participants
|
18 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 0) up to end of treatment (EOT) visit (Day 336)Population: Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed'=participants with both baseline and post-baseline serum chemistry values.
Potentially clinically significant abnormal serum chemistry findings included: Blood Urea Nitrogen (BUN): greater than or equal to (\>=) 10.71 millimoles/liter (mmol/L), creatinine: \>=177 micromoles/liter (µmol/L), bilirubin: \>=34.2 µmol/L, Alanine Aminotransferase (ALT) (units/liter \[U/L\]): \>=3\*upper limit of normal (ULN) Aspartate Aminotransferase (AST) (U/L): \>=3\*ULN, and Gamma Glutamyl Transferase (GGT) (U/L): \>=3\*ULN. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
TEV-48125 225 mg Monthly: Active Rollover Participants
n=518 Participants
Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants
n=412 Participants
Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: Active Rollover Participants
n=513 Participants
Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover CM Participants
n=408 Participants
Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: Active Rollover EM Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675 mg Quarterly: Active Rollover EM Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results
|
26 Participants
|
11 Participants
|
23 Participants
|
27 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 0) up to EOT visit (Day 336)Population: Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed'=participants with both baseline and post-baseline hematology parameter values.
Potentially clinically significant abnormal hematology findings included: hemoglobin: less than (\<) 115 grams/liter (g/L) (in males) or less than or equal to (\<=) 95 g/L (in females), hematocrit: \<0.37 L/L (in male) or \<0.32 L/L (in female), leukocytes: \>=20\*10\^9/L or \<=3\*10\^9/L, eosinophils/leukocytes: \>=10%, and platelets: \>=700\*10\^9/L or \<=75\*10\^9/L. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
TEV-48125 225 mg Monthly: Active Rollover Participants
n=518 Participants
Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants
n=412 Participants
Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: Active Rollover Participants
n=513 Participants
Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover CM Participants
n=408 Participants
Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: Active Rollover EM Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675 mg Quarterly: Active Rollover EM Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Abnormal Hematology Results
|
39 Participants
|
27 Participants
|
40 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 0) up to EOT visit (Day 336)Population: Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed'=participants with both baseline and post-baseline urinalysis values.
Potentially clinically significant abnormal urinalysis findings included: blood: \>=2 unit increase from baseline, urine glucose (milligrams/decilitre \[mg/dL\]): \>=2 unit increase from baseline, ketones (mg/dL): \>=2 unit increase from baseline, urine protein (mg/dL): \>=2 unit increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
TEV-48125 225 mg Monthly: Active Rollover Participants
n=517 Participants
Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants
n=412 Participants
Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: Active Rollover Participants
n=513 Participants
Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover CM Participants
n=408 Participants
Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: Active Rollover EM Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675 mg Quarterly: Active Rollover EM Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests Results
|
170 Participants
|
120 Participants
|
146 Participants
|
128 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 0) up to EOT visit (Day 336)Population: Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed'=participants with both baseline and post-baseline vital signs values.
Potentially clinically significant abnormal vital signs findings included: pulse rate: \<=50 beats/minute (bpm) and decrease of \>=15 bpm, or \>=120 bpm and increase of \>=15 bpm; systolic blood pressure: \<=90 millimeters of mercury (mmHg) and decrease of \>=20 mmHg, or \>=180 mmHg and increase of \>=20 mmHg; diastolic blood pressure: \<=50 mmHg and decrease of \>=15 mmHg or \>=105 mmHg and increase of \>=15 mmHg; respiratory rate: \<10 breaths/minute; and body temperature \>=38.3 degrees centigrade and change of \>=1.1 degrees centigrade. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
TEV-48125 225 mg Monthly: Active Rollover Participants
n=520 Participants
Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants
n=414 Participants
Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: Active Rollover Participants
n=519 Participants
Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover CM Participants
n=415 Participants
Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: Active Rollover EM Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675 mg Quarterly: Active Rollover EM Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values
|
33 Participants
|
24 Participants
|
40 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 0), endpoint (Day 336)Population: Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed' = participants with both baseline and endpoint electrocardiogram findings.
ECG parameters included: heart rate, PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF), QT interval corrected using the Bazett's formula (QTcB) and RR interval. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
TEV-48125 225 mg Monthly: Active Rollover Participants
n=492 Participants
Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants
n=391 Participants
Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: Active Rollover Participants
n=489 Participants
Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover CM Participants
n=386 Participants
Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: Active Rollover EM Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675 mg Quarterly: Active Rollover EM Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters
Normal - Normal
|
295 Participants
|
230 Participants
|
296 Participants
|
239 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters
Normal - Abnormal NCS
|
64 Participants
|
49 Participants
|
67 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters
Normal - Abnormal CS
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters
Abnormal NCS - Normal
|
53 Participants
|
43 Participants
|
60 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters
Abnormal NCS - Abnormal NCS
|
79 Participants
|
69 Participants
|
65 Participants
|
60 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters
Abnormal NCS - Abnormal CS
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters
Abnormal CS - Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters
Abnormal CS - Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters
Abnormal CS - Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 0), endpoint (Day 336)Population: Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed' = participants with both baseline and endpoint coagulation laboratory test results. 'Number analyzed' = participants evaluable for specified categories.
Coagulation parameters included: prothrombin time (PT) (seconds), prothrombin international normalized ratio (INR), activated partial thromboplastin time (aPTT) (seconds). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Shifts from baseline to endpoint were summarized using participant counts grouped into three categories: - Low (below normal range) - Normal (within the normal range of 9.4 to 12.5 seconds) - High (above normal range). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
TEV-48125 225 mg Monthly: Active Rollover Participants
n=516 Participants
Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants
n=410 Participants
Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: Active Rollover Participants
n=513 Participants
Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover CM Participants
n=407 Participants
Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: Active Rollover EM Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675 mg Quarterly: Active Rollover EM Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
PT · Low-Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
PT · Low-Normal
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
PT · Low-High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
PT · Normal-Low
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
PT · Normal-Normal
|
465 Participants
|
374 Participants
|
451 Participants
|
370 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
PT · Normal-High
|
10 Participants
|
14 Participants
|
14 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
PT · High-Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
PT · High-Normal
|
25 Participants
|
9 Participants
|
35 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
PT · High-High
|
11 Participants
|
8 Participants
|
10 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
Prothrombin INR · Low-Low
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
Prothrombin INR · Low-Normal
|
11 Participants
|
11 Participants
|
9 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
Prothrombin INR · Low-High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
Prothrombin INR · Normal-Low
|
15 Participants
|
9 Participants
|
7 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
Prothrombin INR · Normal-Normal
|
468 Participants
|
372 Participants
|
472 Participants
|
366 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
Prothrombin INR · Normal-High
|
5 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
Prothrombin INR · High-Low
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
Prothrombin INR · High-Normal
|
11 Participants
|
6 Participants
|
13 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
Prothrombin INR · High-High
|
5 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
aPTT · Low-Low
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
aPTT · Low-Normal
|
1 Participants
|
7 Participants
|
7 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
aPTT · Low-High
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
aPTT · Normal-Low
|
11 Participants
|
7 Participants
|
10 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
aPTT · Normal-Normal
|
423 Participants
|
334 Participants
|
414 Participants
|
341 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
aPTT · Normal-High
|
18 Participants
|
19 Participants
|
22 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
aPTT · High-Low
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
aPTT · High-Normal
|
43 Participants
|
26 Participants
|
37 Participants
|
26 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
aPTT · High-High
|
17 Participants
|
16 Participants
|
22 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -28 to Day -1), Month 12Population: Safety population included all participants who received at least 1 dose of fremanezumab.
Number of participants who reported treatment-emergent injection site reactions are summarized. Preferred terms from MedDRA version 18.1 were offered without a threshold applied. Injection site reactions included injection site induration, pain, erythema, haemorrhage, pruritus, swelling, bruising, rash, urticaria, warmth, dermatitis, haematoma, inflammation, discolouration, discomfort, hypersensitivity, hypoaesthesia, irritation, oedema, papule, paraesthesia, vesicles and pallor. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
TEV-48125 225 mg Monthly: Active Rollover Participants
n=526 Participants
Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants
n=419 Participants
Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: Active Rollover Participants
n=525 Participants
Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover CM Participants
n=418 Participants
Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: Active Rollover EM Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675 mg Quarterly: Active Rollover EM Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Injection Site Reactions
Injection site induration
|
174 Participants
|
144 Participants
|
134 Participants
|
167 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site pain
|
156 Participants
|
135 Participants
|
140 Participants
|
149 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site erythema
|
144 Participants
|
99 Participants
|
124 Participants
|
130 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site haemorrhage
|
38 Participants
|
21 Participants
|
38 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site pruritus
|
43 Participants
|
17 Participants
|
24 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site swelling
|
10 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site bruising
|
2 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site rash
|
2 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site urticaria
|
2 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site warmth
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site dermatitis
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site haematoma
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site inflammation
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site discolouration
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site discomfort
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site hypersensitivity
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site hypoaesthesia
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site irritation
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site oedema
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site papule
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site paraesthesia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site vesicles
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions
Injection site pallor
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -28 to Day -1), Month 12Population: Safety population included all participants who received at least 1 dose of fremanezumab.
eC-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent.
Outcome measures
| Measure |
TEV-48125 225 mg Monthly: Active Rollover Participants
n=526 Participants
Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants
n=419 Participants
Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: Active Rollover Participants
n=525 Participants
Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover CM Participants
n=418 Participants
Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: Active Rollover EM Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675 mg Quarterly: Active Rollover EM Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)
Suicidal ideation
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)
Suicidal attempt
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day -28 to Day -1), Month 12Population: Full analysis set (FAS):all participants who received at least 1 dose of fremanezumab, had at least 10 days of efficacy assessments by e-diary after first injection for this study. Data for this outcome was collected and reported separately for CM and EM participants.'Overall number of participants analyzed'=participants evaluable for this outcome.
A migraine day was defined as when at least 1 of the following situations occurred: A calendar day(0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for migraine with or without aura; a calendar day(0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day(0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period)\*28. Change was calculated as post-baseline value - baseline value.
Outcome measures
| Measure |
TEV-48125 225 mg Monthly: Active Rollover Participants
n=233 Participants
Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants
n=194 Participants
Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: Active Rollover Participants
n=230 Participants
Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover CM Participants
n=192 Participants
Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants
n=124 Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: Active Rollover EM Participants
n=173 Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants
n=138 Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675 mg Quarterly: Active Rollover EM Participants
n=173 Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period at Month 12
|
-8.2 days/month
Standard Deviation 6.14
|
-7.6 days/month
Standard Deviation 6.87
|
-7.0 days/month
Standard Deviation 6.54
|
-7.8 days/month
Standard Deviation 6.98
|
-4.5 days/month
Standard Deviation 4.20
|
-5.5 days/month
Standard Deviation 4.01
|
-5.5 days/month
Standard Deviation 3.65
|
-5.0 days/month
Standard Deviation 3.78
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day -28 to Day -1), Month 12Population: FAS: all participants who received at least 1 dose of fremanezumab, and had at least 10 days of efficacy assessments by electronic diary after first injection for this study. Data for this outcome was collected and reported separately for CM and EM participants. 'Overall number of participants analyzed' = participants evaluable for this outcome.
Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of any severity for both CM and EM participants was defined as a calendar day (00:00 to 23:59) where the participant (using the electronic headache diary device) reports: a day with headache pain that lasts at least 4 hours with a peak severity of any severity or; a day when the participant used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) \* 28. The change was calculated as post-baseline value - baseline value.
Outcome measures
| Measure |
TEV-48125 225 mg Monthly: Active Rollover Participants
n=233 Participants
Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants
n=194 Participants
Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: Active Rollover Participants
n=230 Participants
Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover CM Participants
n=192 Participants
Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants
n=124 Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: Active Rollover EM Participants
n=173 Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants
n=138 Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675 mg Quarterly: Active Rollover EM Participants
n=173 Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Monthly Average Number of Headache Days of Any Severity During the 4-Week Period at Month 12
|
-7.9 days/month
Standard Deviation 6.01
|
-7.2 days/month
Standard Deviation 6.48
|
-7.1 days/month
Standard Deviation 6.88
|
-7.7 days/month
Standard Deviation 6.79
|
-4.4 days/month
Standard Deviation 4.25
|
-5.0 days/month
Standard Deviation 3.90
|
-5.0 days/month
Standard Deviation 3.63
|
-4.8 days/month
Standard Deviation 3.74
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day -28 to Day -1), Month 12Population: FAS: all participants who received at least 1 dose of fremanezumab, and had at least 10 days of efficacy assessments by electronic diary after first injection for this study. Data for this outcome was collected and reported separately for CM and EM participants. 'Overall number of participants analyzed' = participants evaluable for this outcome.
A migraine day was defined as when at least 1 of the following situations occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for migraine with or without aura; a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period) \* 28.
Outcome measures
| Measure |
TEV-48125 225 mg Monthly: Active Rollover Participants
n=240 Participants
Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants
n=197 Participants
Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: Active Rollover Participants
n=237 Participants
Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover CM Participants
n=195 Participants
Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants
n=125 Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: Active Rollover EM Participants
n=174 Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants
n=139 Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675 mg Quarterly: Active Rollover EM Participants
n=174 Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With At Least 50% Reduction From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period at Month 12
|
59 percentage of participants
|
52 percentage of participants
|
54 percentage of participants
|
54 percentage of participants
|
58 percentage of participants
|
75 percentage of participants
|
68 percentage of participants
|
64 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day -28 to Day -1), Month 12Population: FAS: all participants who received at least 1 dose of fremanezumab, and had at least 10 days of efficacy assessments by electronic diary after first injection for this study. Data for this outcome was collected and reported separately for CM and EM participants. 'Overall number of participants analyzed' = participants evaluable for this outcome.
Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of at least moderate severity for both CM and EM participants was defined as a calendar day (00:00 to 23:59) where the participant (using the electronic headache diary device) reports: a day with headache pain that lasts at least 4 hours with a peak severity of at least moderate severity or; a day when the participant used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) \* 28.
Outcome measures
| Measure |
TEV-48125 225 mg Monthly: Active Rollover Participants
n=240 Participants
Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants
n=197 Participants
Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: Active Rollover Participants
n=237 Participants
Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover CM Participants
n=193 Participants
Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: New/Placebo Rollover EM Participants
n=124 Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 225 mg Monthly: Active Rollover EM Participants
n=174 Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675mg Quarterly:New/Placebo Rollover EM Participants
n=138 Participants
Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
TEV-48125 675 mg Quarterly: Active Rollover EM Participants
n=174 Participants
Participants with EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, 308).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With At Least 50% Reduction From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 4-Week Period
|
62 percentage of participants
|
54 percentage of participants
|
54 percentage of participants
|
56 percentage of participants
|
58 percentage of participants
|
72 percentage of participants
|
67 percentage of participants
|
68 percentage of participants
|
Adverse Events
TEV-48125 225 mg Monthly: New/Placebo Rollover Participants
Serious events: 27 serious events
Other events: 300 other events
Deaths: 0 deaths
TEV-48125 225 mg Monthly: Active Rollover Participants
Serious events: 29 serious events
Other events: 367 other events
Deaths: 0 deaths
TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants
Serious events: 36 serious events
Other events: 284 other events
Deaths: 1 deaths
TEV-48125 675 mg Quarterly: Active Rollover Participants
Serious events: 23 serious events
Other events: 329 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TEV-48125 225 mg Monthly: New/Placebo Rollover Participants
n=418 participants at risk
Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 225 mg Monthly: Active Rollover Participants
n=526 participants at risk
Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants
n=419 participants at risk
Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: Active Rollover Participants
n=525 participants at risk
Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage III
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/365 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/454 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.27%
1/369 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/457 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 2 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Congenital, familial and genetic disorders
Cerebrovascular arteriovenous malformation
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Congenital, familial and genetic disorders
Congenital cyst
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Congenital, familial and genetic disorders
Congenital cystic disease of liver
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Congenital, familial and genetic disorders
Hereditary haemochromatosis
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Eye disorders
Retinal detachment
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Eye disorders
Retinal tear
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.48%
2/418 • Number of events 2 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
General disorders
Chest pain
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
General disorders
Multi-organ failure
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Infections and infestations
Abdominal abscess
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Infections and infestations
Appendicitis
|
0.48%
2/418 • Number of events 2 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Infections and infestations
Bacterial sepsis
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Infections and infestations
Peritonitis
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Infections and infestations
Petrositis
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Infections and infestations
Pneumonia
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.48%
2/419 • Number of events 2 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Investigations
Ammonia increased
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Musculoskeletal and connective tissue disorders
Vertebral osteophyte
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.38%
2/526 • Number of events 2 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.48%
2/419 • Number of events 3 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
High grade B-cell lymphoma Burkitt-like lymphoma
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phyllodes tumour
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/54 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/72 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
2.0%
1/51 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/68 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage unspecified
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Nervous system disorders
Central nervous system lesion
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Nervous system disorders
Cluster headache
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Nervous system disorders
Migraine
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.57%
3/526 • Number of events 4 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 3 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Nervous system disorders
Perineurial cyst
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Nervous system disorders
Primary progressive multiple sclerosis
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Nervous system disorders
Status migrainosus
|
0.48%
2/418 • Number of events 4 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/365 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.22%
1/454 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/369 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/457 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.00%
0/365 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.22%
1/454 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/369 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/457 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.27%
1/365 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/454 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/369 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/457 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
0.00%
0/365 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/454 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.27%
1/369 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/457 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Psychiatric disorders
Adjustment disorder with mixed disturbance of emotion and conduct
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Psychiatric disorders
Suicidal ideation
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.27%
1/365 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/454 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/369 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/457 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.00%
0/365 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.22%
1/454 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/369 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/457 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.27%
1/365 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/454 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/369 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/457 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.27%
1/365 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/454 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/369 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.22%
1/457 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.27%
1/365 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/454 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/369 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/457 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.27%
1/365 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/457 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/369 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/457 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Surgical and medical procedures
Salpingo-oophorectomy
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/525 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Vascular disorders
Deep vein thrombosis
|
0.24%
1/418 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Vascular disorders
Hypertension
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/526 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.24%
1/419 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/418 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.19%
1/526 • Number of events 1 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/419 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
0.00%
0/525 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
Other adverse events
| Measure |
TEV-48125 225 mg Monthly: New/Placebo Rollover Participants
n=418 participants at risk
Participants with CM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 225 mg Monthly: Active Rollover Participants
n=526 participants at risk
Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, received 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants
n=419 participants at risk
Participants with CM or EM who were randomized to the placebo treatment group or participants who did not rollover from the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
TEV-48125 675 mg Quarterly: Active Rollover Participants
n=525 participants at risk
Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, received fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).
|
|---|---|---|---|---|
|
General disorders
Injection site erythema
|
31.1%
130/418 • Number of events 430 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
27.4%
144/526 • Number of events 446 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
23.6%
99/419 • Number of events 284 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
23.6%
124/525 • Number of events 386 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
General disorders
Injection site haemorrhage
|
8.1%
34/418 • Number of events 43 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
7.2%
38/526 • Number of events 66 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
5.0%
21/419 • Number of events 38 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
7.2%
38/525 • Number of events 62 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
General disorders
Injection site induration
|
40.0%
167/418 • Number of events 717 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
33.1%
174/526 • Number of events 753 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
34.4%
144/419 • Number of events 543 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
25.5%
134/525 • Number of events 666 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
General disorders
Injection site pain
|
35.6%
149/418 • Number of events 980 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
29.7%
156/526 • Number of events 982 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
32.2%
135/419 • Number of events 981 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
26.7%
140/525 • Number of events 811 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
General disorders
Injection site pruritus
|
7.4%
31/418 • Number of events 101 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
8.2%
43/526 • Number of events 107 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
4.1%
17/419 • Number of events 64 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
4.6%
24/525 • Number of events 64 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Infections and infestations
Bronchitis
|
5.7%
24/418 • Number of events 25 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
2.9%
15/526 • Number of events 16 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
4.8%
20/419 • Number of events 22 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
4.6%
24/525 • Number of events 26 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Infections and infestations
Influenza
|
3.3%
14/418 • Number of events 18 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
5.1%
27/526 • Number of events 29 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
1.9%
8/419 • Number of events 9 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
4.8%
25/525 • Number of events 28 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Infections and infestations
Nasopharyngitis
|
10.3%
43/418 • Number of events 61 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
13.1%
69/526 • Number of events 107 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
8.8%
37/419 • Number of events 58 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
13.0%
68/525 • Number of events 108 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Infections and infestations
Sinusitis
|
7.2%
30/418 • Number of events 40 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
5.1%
27/526 • Number of events 28 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
6.7%
28/419 • Number of events 35 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
5.9%
31/525 • Number of events 38 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.2%
55/418 • Number of events 65 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
11.8%
62/526 • Number of events 76 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
17.4%
73/419 • Number of events 97 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
12.0%
63/525 • Number of events 78 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
|
Infections and infestations
Urinary tract infection
|
6.0%
25/418 • Number of events 38 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
5.1%
27/526 • Number of events 43 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
6.2%
26/419 • Number of events 29 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
6.3%
33/525 • Number of events 37 • Baseline (Day 0) up to follow-up visit (Day 533)
Safety population included all participants who received at least 1 dose of fremanezumab.
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 1-888-483-8279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER