Skip to main content

Table 3 Incidence of AEs (safety set)

From: Effectiveness, safety and health-related quality of life of multiple sclerosis patients treated with fingolimod: results from a 12-month, real-world, observational PERFORMS study in the Middle East

 

Fingolimod cohort

N = 177

Other DMTs cohort

N = 87

Safety profile, n (%)

 Patients with any AE

106 (59.9)

44 (50.6)

 Patients with any AE leading to drug discontinuation

29 (16.4)

5 (5.7)

 Patients with an SAE

10 (5.6)

1 (1.1)

 Deaths

0 (0.0)

0 (0.0)

Most frequent AEs (≥3% of patients for any group; n [%]; preferred terms)

 MS relapse

19 (10.7)

7 (8.0)

 Lymphopaenia

14 (7.9)

0 (0.0)

 Hepatic enzyme increased

12 (6.8)

0 (0.0)

 Fatigue

11 (6.2)

6 (6.9)

 Muscular weakness

10 (5.6)

5 (5.7)

 Leukopaenia

9 (5.1)

3 (3.4)

 Lymphocyte count decreased

9 (5.1)

0 (0.0)

 Dizziness

8 (4.5)

2 (2.3)

 Gait disturbance

7 (4.0)

6 (6.9)

 MS worsening

4 (2.3)

4 (4.6)

 Pain in extremity

6 (3.4)

2 (2.3)

 Headache

4 (2.3)

3 (3.4)

 Micturition urgency

3 (1.7)

3 (3.4)

 Influenza

0 (0.0)

4 (4.6)

 Paraesthesia

0 (0.0)

4 (4.6)

Selected AEs, n (%)

 Symptomatic bradyarrhythmia

0 (0.0)

0 (0.0)

 Macular oedema

0 (0.0)

0 (0.0)

 Increase in liver enzymes

14 (8.9)

2 (2.8)

 Any infection

4 (2.5)

2 (2.8)

 Other (any other AE)

50 (31.6)

28 (38.9)

  1. Safety set: all AEs are reported in patients on MOI or after a switch; if no medication is taken at the time of the AE start, the AE will be reported under the category of the medication taken within the last 45 days
  2. AE adverse event, DMT disease-modifying treatment, MOI medication of interest, MS multiple sclerosis, SAE serious adverse event