Table 4.
Serious Adverse Events—MedDRA classification (By System Organ Class)
| System Organ Class, n (%) | Related to death |
Related to hospitalisation |
||
|---|---|---|---|---|
| Placebo N = 383 | Riluzole N = 382 | Placebo N = 383 | Riluzole N = 382 | |
| Respiratory, thoracic and mediastinal disorders | 60 (25) | 65 (29) | 33 (14) | 40 (12) |
| General disorders and administration site conditions | 56 (24) | 56 (25) | 27 (12) | 39 (12) |
| Infections and infestations | 37 (16) | 49 (22) | 38 (16) | 50 (15) |
| Cardiac disorders | 25 (11) | 14 (6) | 3a (1) | 10 (3) |
| Surgical and medical procedures | 13 (6) | 8 (4) | 13 (6) | 19 (6) |
| Gastrointestinal disorders | 13 (6) | 7 (3) | 23a (10) | 41 (13) |
| Nervous system disorders | 12 (5) | 7 (3) | 22 (9) | 25 (8) |
| Metabolism and nutrition disorders | 3 (1) | 6 (3) | 10 (4) | 8 (2) |
| Injury, poisoning and procedural complications | 6 (3) | 2 (1) | 48 (20) | 49 (15) |
| Neoplasms benign, malignant and unspecified | 5 (2) | 2 (1 | 2 (1) | 2 (1) |
| Psychiatric disorders | 2 (1) | 4 (2) | 13 (6) | 19 (6) |
| Skin and subcutaneous tissue disorders | 3 (1) | 1 (0.4) | 3 (1) | 1 (0.3) |
| Vascular disorders | – | 3 (1) | 7 (3) | 8 (2) |
| Renal and urinary disorders | 2 (1) | – | 17a (7) | 7 (2) |
| Reproductive system and breast disorders | 1 (0.4) | – | 3 (1) | 1 (0.3) |
| Hepatobiliary disorders | – | – | 3 (1) | 3 (1) |
| Investigations | – | – | 5 (2) | 1 (0.3) |
| Musculoskeletal and connective tissue disorders | – | – | 3 (1) | 3 (1) |
| Blood and lymphatic system disorders | – | – | 3 (1) | – |
| Eye disorders | – | – | 2 (1) | – |
| Ear and labyrinth disorders | – | – | – | 1 (0.3) |
| Total events | 238 | 224 | 235 | 327 |
| Total patients, Number of events (percentage of patients) | 169 (44) | 176 (46) | 145 (38) | 164 (43) |
a Statistically significant difference between treatment by the Fischer exact test.