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Table 3 Adverse events (AEs)

From: Sub-analysis of geographical variations in the 2-year observational COPTIMIZE trial of patients with relapsing–remitting multiple sclerosis converting to glatiramer acetate

Patients, events/patients (%a)

LA (n = 263)

CWE (n = 248)

EE (n = 157)

Most common AEs by preferred term

   

  Dyspnea

5/4 (1.5)

4/3 (1.2)

1/1 (0.6)

  Syncope

2/2 (0.8)

2/2 (0.8)

0/0 (0.0)

  Injection site reaction

2/2 (0.8)

8/8 (3.2)

0/0 (0.0)

  Injection site pain

2/2 (0.8)

14/10 (4.0)

0/0 (0.0)

  Injection site induration

1/1 (0.4)

5/5 (2.0)

0/0 (0.0)

  Fatigue

1/1 (0.4)

3/3 (1.2)

0/0 (0.0)

  Arthralgia

1/1 (0.4)

3/3 (1.2)

0/0 (0.0)

  Rash

0/0 (0.0)

2/2 (0.8)

2/2 (1.3)

  Anxiety

0/0 (0.0)

1/1 (0.4)

1/1 (0.6)

Most common AE classified by system organ class

   

  General disorders and administration site conditions

16/13 (4.9)

55/32 (12.9)

5/4 (2.6)

  Nervous system disorders

10/10 (3.8)

9/8 (3.2)

0/0 (0.0)

  Respiratory, thoracic, and mediastinal disorders

7/6 (2.3)

4/3 (1.2)

0/0 (0.0)

Severity of AE, events/patients

   

  Mild

19/12 (4.6)

40/28 (11.3)

0/0 (0.0)

  Moderate

22/12 (4.6)

62/38 (15.3)

5/5 (3.2)

  Severe

13/6 (2.3)

14/9 (3.6)

5/3 (1.9)

  Data unavailable

4/2 (0.8)

7/5 (2.0)

2/2 (1.3)

Patient-reported assessment of AEs after glatiramer acetate treatmentb

   

  Improved with glatiramer acetate

209 (80.4)

162 (66.1)

58 (38.4)

  Same with glatiramer acetate

41 (15.8)

62 (25.3)

87 (57.6)

  Worse with glatiramer acetate

10 (3.9)

21 (8.6)

6 (4.0)

  Data unavailable

3

3

6

  1. aPercentage reported as the proportion of patients experiencing events
  2. bAdjusted percentage of patients with data available