Trial Outcomes & Findings for Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and Effectiveness (NCT NCT00203021)
NCT ID: NCT00203021
Last Updated: 2020-02-18
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. 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. Any AEs included both serious and non-serious AEs. 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
PHASE4
Target enrollment
208 participants
Primary outcome timeframe
Baseline up to Month 288
Results posted on
2020-02-18
Participant Flow
Participants who participated in both or either Studies 01-9001 (double-blind \[DB\] placebo-controlled study) and 01-9001E (DB extension study) were eligible to enter into this open-label extension study. Note that the 01-9001 and 01-9001E studies predate NCT assignments.
A total of 209 participants were screened; 208 participants met entry criteria and were enrolled in this study.
Participant milestones
| Measure |
Glatiramer Acetate: Delayed Start
Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 milligrams (mg) subcutaneous (SC) injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg three times weekly (TIW). The treatment continued for up to 288 months.
|
Glatiramer Acetate: Early Start
Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
101
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
107
|
101
|
|
Overall Study
COMPLETED
|
28
|
24
|
|
Overall Study
NOT COMPLETED
|
79
|
77
|
Reasons for withdrawal
| Measure |
Glatiramer Acetate: Delayed Start
Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 milligrams (mg) subcutaneous (SC) injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg three times weekly (TIW). The treatment continued for up to 288 months.
|
Glatiramer Acetate: Early Start
Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
|
|---|---|---|
|
Overall Study
Death
|
4
|
1
|
|
Overall Study
Adverse Event
|
10
|
5
|
|
Overall Study
Withdrawal by Subject
|
45
|
48
|
|
Overall Study
Lost to Follow-up
|
9
|
7
|
|
Overall Study
Other than specified
|
11
|
16
|
Baseline Characteristics
Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and Effectiveness
Baseline characteristics by cohort
| Measure |
Glatiramer Acetate: Delayed Start
n=107 Participants
Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
|
Glatiramer Acetate: Early Start
n=101 Participants
Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.9 years
STANDARD_DEVIATION 6.57 • n=99 Participants
|
37.2 years
STANDARD_DEVIATION 5.79 • n=107 Participants
|
37.1 years
STANDARD_DEVIATION 6.19 • n=206 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
154 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
105 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
206 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
101 Participants
n=99 Participants
|
97 Participants
n=107 Participants
|
198 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Missing
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 288Population: 01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. Any AEs included both serious and non-serious AEs. A summary of other non-serious AEs and all serious AEs, regardless of causality, is located in Reported AE section.
Outcome measures
| Measure |
Glatiramer Acetate: Delayed Start
n=107 Participants
Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
|
Glatiramer Acetate: Early Start
n=101 Participants
Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any AEs
|
107 participants
|
100 participants
|
|
Number of Participants With Adverse Events (AEs)
Serious AEs
|
44 participants
|
38 participants
|
PRIMARY outcome
Timeframe: Baseline, Month 288Population: 01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
The EDSS uses an ordinal scale to assess neurologic impairment in Multiple Sclerosis based on a neurological examination. Scores in each of 7 functional systems (Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral) and an ambulation score were combined to determine the total EDSS score, ranging from 0 (normal) to 10 (death due to Multiple Sclerosis).
Outcome measures
| Measure |
Glatiramer Acetate: Delayed Start
n=28 Participants
Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
|
Glatiramer Acetate: Early Start
n=24 Participants
Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
|
|---|---|---|
|
Change From Baseline in Kurtzke Expanded Disability Status Scale (EDSS) Score at Month 288
Baseline
|
2.34 units on a scale
Standard Deviation 1.599
|
2.23 units on a scale
Standard Deviation 1.406
|
|
Change From Baseline in Kurtzke Expanded Disability Status Scale (EDSS) Score at Month 288
Change at Month 288
|
1.64 units on a scale
Standard Deviation 1.962
|
1.06 units on a scale
Standard Deviation 1.896
|
Adverse Events
Glatiramer Acetate: Delayed Start
Serious events: 44 serious events
Other events: 107 other events
Deaths: 4 deaths
Glatiramer Acetate: Early Start
Serious events: 38 serious events
Other events: 100 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Glatiramer Acetate: Delayed Start
n=107 participants at risk
Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
|
Glatiramer Acetate: Early Start
n=101 participants at risk
Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
|
|---|---|---|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.93%
1/107 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Vascular disorders
Arteriosclerosis
|
0.93%
1/107 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Vascular disorders
Flushing
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Vascular disorders
Haematoma
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
2.0%
2/101 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
3.0%
3/101 • Number of events 3 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Cardiac disorders
Coronary artery disease
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Cardiac disorders
Myocardial infarction
|
1.9%
2/107 • Number of events 3 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Congenital, familial and genetic disorders
Diverticulitis Meckel's
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Endocrine disorders
Thyroid cyst
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
2.0%
2/101 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Ileus
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Nausea
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
2.0%
2/101 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Vomiting
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
2.0%
2/101 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Adhesion
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Asthenia
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Chest discomfort
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Chest pain
|
1.9%
2/107 • Number of events 3 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.0%
5/101 • Number of events 6 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Complication associated with device
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Death
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Facial pain
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Feeling abnormal
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Haemorrhagic cyst
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Influenza like illness
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Injection site inflammation
|
0.93%
1/107 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Non-cardiac chest pain
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Peripheral swelling
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Pyrexia
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Strangulated hernia
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Hepatobiliary disorders
Biliary cirrhosis primary
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.9%
2/107 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Atypical pneumonia
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 5 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Catheter site abscess
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Cellulitis
|
1.9%
2/107 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Cystitis
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Gastroenteritis
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Infection
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
2.0%
2/101 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
2.0%
2/101 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Mastitis
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Meningitis aseptic
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Peritonitis
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Vascular disorders
Hypotension
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Pneumonia
|
1.9%
2/107 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
2.0%
2/101 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Post procedural sepsis
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Pyelonephritis
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Sepsis
|
1.9%
2/107 • Number of events 3 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Septic shock
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Urinary tract infection
|
4.7%
5/107 • Number of events 7 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
4.0%
4/101 • Number of events 4 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Wound infection fungal
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Biliary anastomosis complication
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Failure to anastomose
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
2/107 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
2.8%
3/107 • Number of events 3 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Gastrointestinal injury
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
2.0%
2/101 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.9%
2/107 • Number of events 3 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
2.8%
3/107 • Number of events 3 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
2.0%
2/101 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Investigations
Cardiac output decreased
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Investigations
Weight decreased
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.7%
5/107 • Number of events 6 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
2.0%
2/101 • Number of events 3 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
3/107 • Number of events 3 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.93%
1/107 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
2.0%
2/101 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
1.9%
2/107 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 3 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage III
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
1.9%
2/107 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
4.0%
4/101 • Number of events 5 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Dizziness
|
1.9%
2/107 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Drug withdrawal convulsions
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Multiple sclerosis
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Muscle spasticity
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
2.0%
2/101 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Seizure
|
2.8%
3/107 • Number of events 3 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Sensory loss
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Syncope
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Transient global amnesia
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Trigeminal neuralgia
|
1.9%
2/107 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
1.9%
2/107 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Psychiatric disorders
Anger
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Psychiatric disorders
Anxiety
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Psychiatric disorders
Confusional state
|
1.9%
2/107 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.0%
5/101 • Number of events 8 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
2.0%
2/101 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Renal and urinary disorders
Calculus urethral
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Renal and urinary disorders
Renal pain
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Reproductive system and breast disorders
Breast disorder
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Reproductive system and breast disorders
Cystocele
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.9%
2/107 • Number of events 3 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Reproductive system and breast disorders
Pelvic adhesions
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Reproductive system and breast disorders
Rectocele
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Respiratory, thoracic and mediastinal disorders
Reflux laryngitis
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Surgical and medical procedures
Appendicectomy
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Surgical and medical procedures
Bladder repair
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Surgical and medical procedures
Central venous catheterisation
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Surgical and medical procedures
Femoral hernia repair
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Surgical and medical procedures
Hysterectomy
|
1.9%
2/107 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
2.0%
2/101 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Surgical and medical procedures
Hysterosalpingo-oophorectomy
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Surgical and medical procedures
Small intestinal resection
|
0.93%
1/107 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.00%
0/101 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
Other adverse events
| Measure |
Glatiramer Acetate: Delayed Start
n=107 participants at risk
Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
|
Glatiramer Acetate: Early Start
n=101 participants at risk
Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.3%
11/107 • Number of events 11 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
8.9%
9/101 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
9.3%
10/107 • Number of events 23 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
6.9%
7/101 • Number of events 57 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Cardiac disorders
Palpitations
|
11.2%
12/107 • Number of events 31 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
8.9%
9/101 • Number of events 28 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Cardiac disorders
Tachycardia
|
5.6%
6/107 • Number of events 13 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
7.9%
8/101 • Number of events 21 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Ear and labyrinth disorders
Ear pain
|
6.5%
7/107 • Number of events 10 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
10.9%
11/101 • Number of events 14 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Ear and labyrinth disorders
Tinnitus
|
10.3%
11/107 • Number of events 16 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
9.9%
10/101 • Number of events 14 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Ear and labyrinth disorders
Vertigo
|
16.8%
18/107 • Number of events 28 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
15.8%
16/101 • Number of events 31 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Endocrine disorders
Hypothyroidism
|
3.7%
4/107 • Number of events 4 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 7 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Eye disorders
Diplopia
|
13.1%
14/107 • Number of events 18 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
8.9%
9/101 • Number of events 12 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Eye disorders
Dry eye
|
5.6%
6/107 • Number of events 8 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
2.0%
2/101 • Number of events 3 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Eye disorders
Eye pain
|
5.6%
6/107 • Number of events 11 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
15.8%
16/101 • Number of events 32 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Eye disorders
Vision blurred
|
22.4%
24/107 • Number of events 37 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
18.8%
19/101 • Number of events 33 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Eye disorders
Visual acuity reduced
|
3.7%
4/107 • Number of events 5 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
8.9%
9/101 • Number of events 12 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Eye disorders
Visual impairment
|
12.1%
13/107 • Number of events 16 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
8.9%
9/101 • Number of events 11 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
12.1%
13/107 • Number of events 19 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
12.9%
13/101 • Number of events 16 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.3%
10/107 • Number of events 21 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
15.8%
16/101 • Number of events 25 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.5%
8/107 • Number of events 11 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 6 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Anal incontinence
|
10.3%
11/107 • Number of events 18 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
11.9%
12/101 • Number of events 28 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Constipation
|
21.5%
23/107 • Number of events 38 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
19.8%
20/101 • Number of events 30 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Defaecation urgency
|
4.7%
5/107 • Number of events 11 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 8 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.4%
25/107 • Number of events 45 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
26.7%
27/101 • Number of events 48 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.2%
12/107 • Number of events 22 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
9.9%
10/101 • Number of events 14 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Dysphagia
|
10.3%
11/107 • Number of events 17 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
7.9%
8/101 • Number of events 16 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Gastritis
|
5.6%
6/107 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
2.0%
2/101 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.2%
12/107 • Number of events 15 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
13.9%
14/101 • Number of events 16 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.93%
1/107 • Number of events 4 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 7 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Large intestine polyp
|
5.6%
6/107 • Number of events 6 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.0%
5/101 • Number of events 5 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Nausea
|
29.0%
31/107 • Number of events 66 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
23.8%
24/101 • Number of events 59 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Toothache
|
5.6%
6/107 • Number of events 8 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
16/107 • Number of events 22 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
13.9%
14/101 • Number of events 28 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Asthenia
|
7.5%
8/107 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
12.9%
13/101 • Number of events 19 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Chest discomfort
|
15.9%
17/107 • Number of events 64 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
12.9%
13/101 • Number of events 66 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Chest pain
|
11.2%
12/107 • Number of events 15 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Chills
|
8.4%
9/107 • Number of events 26 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.0%
5/101 • Number of events 6 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Fatigue
|
54.2%
58/107 • Number of events 145 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
58.4%
59/101 • Number of events 159 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Feeling hot
|
4.7%
5/107 • Number of events 6 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 11 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Gait disturbance
|
13.1%
14/107 • Number of events 20 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
17.8%
18/101 • Number of events 25 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Ill-defined disorder
|
7.5%
8/107 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
3.0%
3/101 • Number of events 4 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Injection site bruising
|
10.3%
11/107 • Number of events 18 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Injection site erythema
|
63.6%
68/107 • Number of events 87 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
32.7%
33/101 • Number of events 40 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Injection site haemorrhage
|
7.5%
8/107 • Number of events 12 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
4.0%
4/101 • Number of events 5 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Injection site induration
|
18.7%
20/107 • Number of events 28 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 18 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Injection site mass
|
24.3%
26/107 • Number of events 68 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
13.9%
14/101 • Number of events 24 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Injection site pain
|
48.6%
52/107 • Number of events 111 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
14.9%
15/101 • Number of events 19 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Injection site pruritus
|
23.4%
25/107 • Number of events 29 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
10.9%
11/101 • Number of events 15 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Injection site reaction
|
7.5%
8/107 • Number of events 11 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
4.0%
4/101 • Number of events 5 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Injection site swelling
|
31.8%
34/107 • Number of events 43 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
10.9%
11/101 • Number of events 12 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Injection site urticaria
|
11.2%
12/107 • Number of events 28 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
7.9%
8/101 • Number of events 8 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Injection site warmth
|
9.3%
10/107 • Number of events 14 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
4.0%
4/101 • Number of events 4 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Oedema peripheral
|
9.3%
10/107 • Number of events 13 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
6.9%
7/101 • Number of events 10 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Pain
|
15.0%
16/107 • Number of events 31 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
7.9%
8/101 • Number of events 12 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Peripheral swelling
|
12.1%
13/107 • Number of events 16 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
7.9%
8/101 • Number of events 10 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
General disorders
Pyrexia
|
10.3%
11/107 • Number of events 23 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
14.9%
15/101 • Number of events 21 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Immune system disorders
Hypersensitivity
|
7.5%
8/107 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
7.9%
8/101 • Number of events 11 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Immune system disorders
Seasonal allergy
|
14.0%
15/107 • Number of events 24 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
12.9%
13/101 • Number of events 22 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Bronchitis
|
18.7%
20/107 • Number of events 35 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
21.8%
22/101 • Number of events 44 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Cellulitis
|
6.5%
7/107 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 7 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Conjunctivitis
|
7.5%
8/107 • Number of events 13 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.0%
5/101 • Number of events 5 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Cystitis
|
12.1%
13/107 • Number of events 24 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.0%
5/101 • Number of events 5 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Ear infection
|
10.3%
11/107 • Number of events 13 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
8.9%
9/101 • Number of events 12 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Fungal infection
|
8.4%
9/107 • Number of events 11 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
12.9%
13/101 • Number of events 27 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Gastroenteritis
|
6.5%
7/107 • Number of events 7 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.0%
5/101 • Number of events 7 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Gastroenteritis viral
|
15.9%
17/107 • Number of events 22 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
15.8%
16/101 • Number of events 24 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Herpes zoster
|
6.5%
7/107 • Number of events 12 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
9.9%
10/101 • Number of events 12 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Influenza
|
30.8%
33/107 • Number of events 55 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
24.8%
25/101 • Number of events 40 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Nasopharyngitis
|
29.9%
32/107 • Number of events 98 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
27.7%
28/101 • Number of events 74 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Oral herpes
|
6.5%
7/107 • Number of events 12 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 15 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Pharyngitis
|
5.6%
6/107 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
4.0%
4/101 • Number of events 4 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Pharyngitis streptococcal
|
8.4%
9/107 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
6.9%
7/101 • Number of events 7 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Pneumonia
|
8.4%
9/107 • Number of events 10 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
8.9%
9/101 • Number of events 11 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Sinusitis
|
34.6%
37/107 • Number of events 115 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
36.6%
37/101 • Number of events 108 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Tooth abscess
|
9.3%
10/107 • Number of events 10 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.0%
5/101 • Number of events 7 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Tooth infection
|
2.8%
3/107 • Number of events 5 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
8.9%
9/101 • Number of events 10 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Upper respiratory tract infection
|
61.7%
66/107 • Number of events 283 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
63.4%
64/101 • Number of events 282 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Urinary tract infection
|
47.7%
51/107 • Number of events 281 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
47.5%
48/101 • Number of events 248 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Vaginal infection
|
4.7%
5/107 • Number of events 13 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
6.9%
7/101 • Number of events 7 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
8.4%
9/107 • Number of events 19 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
10.9%
11/101 • Number of events 18 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Contusion
|
25.2%
27/107 • Number of events 49 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
19.8%
20/101 • Number of events 28 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Fall
|
29.0%
31/107 • Number of events 78 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
34.7%
35/101 • Number of events 79 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
14.0%
15/107 • Number of events 21 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
12.9%
13/101 • Number of events 15 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
8.4%
9/107 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 7 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Joint injury
|
2.8%
3/107 • Number of events 3 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
8.9%
9/101 • Number of events 10 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Laceration
|
12.1%
13/107 • Number of events 17 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
12.9%
13/101 • Number of events 16 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
10.3%
11/107 • Number of events 13 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
11.9%
12/101 • Number of events 15 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
8.4%
9/107 • Number of events 11 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
12.9%
13/101 • Number of events 13 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
7.5%
8/107 • Number of events 12 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
3.0%
3/101 • Number of events 8 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
13.1%
14/107 • Number of events 31 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
12.9%
13/101 • Number of events 24 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
3.7%
4/107 • Number of events 4 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
6.9%
7/101 • Number of events 8 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
5.6%
6/107 • Number of events 8 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 6 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
7.5%
8/107 • Number of events 15 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
6.9%
7/101 • Number of events 8 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Investigations
Weight decreased
|
6.5%
7/107 • Number of events 15 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
4.0%
4/101 • Number of events 6 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
8.4%
9/107 • Number of events 13 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
13.9%
14/101 • Number of events 16 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
29.9%
32/107 • Number of events 60 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
33.7%
34/101 • Number of events 91 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.7%
4/107 • Number of events 5 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
6.9%
7/101 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
31.8%
34/107 • Number of events 82 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
35.6%
36/101 • Number of events 74 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
2.8%
3/107 • Number of events 8 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 8 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
6.5%
7/107 • Number of events 11 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
3.7%
4/107 • Number of events 4 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
9.9%
10/101 • Number of events 16 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
18.7%
20/107 • Number of events 35 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
23.8%
24/101 • Number of events 47 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
6.5%
7/107 • Number of events 12 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
3.0%
3/101 • Number of events 3 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
42.1%
45/107 • Number of events 81 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
37.6%
38/101 • Number of events 78 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.8%
18/107 • Number of events 27 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
11.9%
12/101 • Number of events 16 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
15.9%
17/107 • Number of events 35 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
18.8%
19/101 • Number of events 34 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
6/107 • Number of events 6 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
8.9%
9/101 • Number of events 15 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
15.9%
17/107 • Number of events 25 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
7.9%
8/101 • Number of events 13 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
5.6%
6/107 • Number of events 6 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 7 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
8.4%
9/107 • Number of events 12 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
8.9%
9/101 • Number of events 11 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
30.8%
33/107 • Number of events 72 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
36.6%
37/101 • Number of events 73 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
5.6%
6/107 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.0%
5/101 • Number of events 11 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
5.6%
6/107 • Number of events 7 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
4.0%
4/101 • Number of events 4 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Amnesia
|
4.7%
5/107 • Number of events 10 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
7.9%
8/101 • Number of events 14 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Balance disorder
|
21.5%
23/107 • Number of events 50 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
26.7%
27/101 • Number of events 47 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Burning sensation
|
8.4%
9/107 • Number of events 17 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
9.9%
10/101 • Number of events 28 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Cognitive disorder
|
7.5%
8/107 • Number of events 11 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 8 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Coordination abnormal
|
4.7%
5/107 • Number of events 6 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
6.9%
7/101 • Number of events 11 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Dizziness
|
36.4%
39/107 • Number of events 85 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
28.7%
29/101 • Number of events 56 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Dysaesthesia
|
6.5%
7/107 • Number of events 8 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
6.9%
7/101 • Number of events 10 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Dysarthria
|
9.3%
10/107 • Number of events 19 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
8.9%
9/101 • Number of events 12 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Headache
|
43.0%
46/107 • Number of events 89 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
39.6%
40/101 • Number of events 96 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Hemiparesis
|
5.6%
6/107 • Number of events 7 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
7.9%
8/101 • Number of events 10 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Hyperaesthesia
|
5.6%
6/107 • Number of events 19 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 6 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Hypoaesthesia
|
38.3%
41/107 • Number of events 97 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
41.6%
42/101 • Number of events 106 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Memory impairment
|
11.2%
12/107 • Number of events 20 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
8.9%
9/101 • Number of events 15 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Migraine
|
8.4%
9/107 • Number of events 14 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
12.9%
13/101 • Number of events 25 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Muscle spasticity
|
15.0%
16/107 • Number of events 21 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
22.8%
23/101 • Number of events 38 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Optic neuritis
|
5.6%
6/107 • Number of events 6 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.0%
5/101 • Number of events 8 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Paraesthesia
|
30.8%
33/107 • Number of events 66 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
31.7%
32/101 • Number of events 75 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/107 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
6.9%
7/101 • Number of events 10 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Sensory disturbance
|
5.6%
6/107 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.0%
5/101 • Number of events 8 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Sinus headache
|
3.7%
4/107 • Number of events 5 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
6.9%
7/101 • Number of events 7 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Tremor
|
15.0%
16/107 • Number of events 39 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
8.9%
9/101 • Number of events 33 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Nervous system disorders
Visual field defect
|
1.9%
2/107 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 6 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Psychiatric disorders
Affect lability
|
5.6%
6/107 • Number of events 16 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 10 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Psychiatric disorders
Anxiety
|
28.0%
30/107 • Number of events 53 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
27.7%
28/101 • Number of events 65 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Psychiatric disorders
Depression
|
30.8%
33/107 • Number of events 86 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
39.6%
40/101 • Number of events 118 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Psychiatric disorders
Emotional distress
|
3.7%
4/107 • Number of events 13 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
7.9%
8/101 • Number of events 21 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Psychiatric disorders
Insomnia
|
30.8%
33/107 • Number of events 90 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
35.6%
36/101 • Number of events 92 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Psychiatric disorders
Stress
|
3.7%
4/107 • Number of events 5 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 10 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Renal and urinary disorders
Dysuria
|
8.4%
9/107 • Number of events 13 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
6.9%
7/101 • Number of events 14 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Renal and urinary disorders
Micturition urgency
|
20.6%
22/107 • Number of events 41 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
30.7%
31/101 • Number of events 60 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Renal and urinary disorders
Pollakiuria
|
16.8%
18/107 • Number of events 35 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
25.7%
26/101 • Number of events 35 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Renal and urinary disorders
Urinary hesitation
|
7.5%
8/107 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
9.9%
10/101 • Number of events 15 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Renal and urinary disorders
Urinary incontinence
|
15.9%
17/107 • Number of events 38 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
11.9%
12/101 • Number of events 28 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Renal and urinary disorders
Urinary retention
|
6.5%
7/107 • Number of events 17 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
10.9%
11/101 • Number of events 16 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.7%
4/107 • Number of events 4 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 16 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Reproductive system and breast disorders
Menorrhagia
|
5.6%
6/107 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.0%
5/101 • Number of events 5 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
9.3%
10/107 • Number of events 30 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
6.9%
7/101 • Number of events 12 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
5.6%
6/107 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
2.0%
2/101 • Number of events 4 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
3.7%
4/107 • Number of events 6 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 10 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.1%
13/107 • Number of events 25 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
11.9%
12/101 • Number of events 22 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
23.4%
25/107 • Number of events 68 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
10.9%
11/101 • Number of events 25 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
6/107 • Number of events 6 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
8.9%
9/101 • Number of events 21 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.6%
22/107 • Number of events 41 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
13.9%
14/101 • Number of events 26 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
6.5%
7/107 • Number of events 10 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
4.0%
4/101 • Number of events 6 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.9%
2/107 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
6.9%
7/101 • Number of events 7 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.6%
6/107 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
6.9%
7/101 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.5%
8/107 • Number of events 13 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
4.0%
4/101 • Number of events 5 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.5%
7/107 • Number of events 10 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 2 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
15.0%
16/107 • Number of events 18 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
8.9%
9/101 • Number of events 12 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.6%
6/107 • Number of events 7 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.5%
7/107 • Number of events 11 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 14 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.9%
17/107 • Number of events 26 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
20.8%
21/101 • Number of events 34 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.5%
7/107 • Number of events 8 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
7.9%
8/101 • Number of events 14 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Surgical and medical procedures
Tooth extraction
|
6.5%
7/107 • Number of events 9 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
0.99%
1/101 • Number of events 1 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Vascular disorders
Flushing
|
20.6%
22/107 • Number of events 104 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
8.9%
9/101 • Number of events 67 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Vascular disorders
Hot flush
|
3.7%
4/107 • Number of events 7 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
5.9%
6/101 • Number of events 12 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
|
Vascular disorders
Hypertension
|
10.3%
11/107 • Number of events 14 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
14.9%
15/101 • Number of events 20 • Baseline up to Month 288
01-9004 included participants originally randomized to placebo in 01-9001 and/or 01-9001E studies and switched to glatiramer acetate 20 mg at the start of the 01-9004 study; and participants originally randomized to the glatiramer acetate 20 mg group in 01-9001 and/or 01-9001E studies who continued on this dose in the 01-9004 study.
|
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