Table 5 Treatment-emergent adverse events
From: Randomized, double-blind, placebo-controlled trial of rapamycin in amyotrophic lateral sclerosis
Treatment-emergent adverse events, MedDRA preferred term | PLACEBO (n = 21) | Rapamycin 1 mg/m2/d (n = 21) | Rapamycin 2 mg/m2/d (n = 21) | |||
|---|---|---|---|---|---|---|
n | % | n | % | n | % | |
Blood and lymphatic system disorders | 0 | 0.0% | 1 | 4.8% | 0 | 0.0% |
Depression and suicide/self-injury | 0 | 0.0% | 1 | 4.8% | 0 | 0.0% |
Ear and labyrinth disorders | 1 | 4.8% | 0 | 0.0% | 0 | 0.0% |
Eye disorders | 1 | 4.8% | 0 | 0.0% | 0 | 0.0% |
Gastrointestinal disorders | 0 | 0.0% | 1 | 4.8% | 2 | 9.5% |
General disorders and administration site conditions | 1 | 4.8% | 1 | 4.8% | 0 | 0.0% |
Infections and infestations | 4 | 19.0% | 3 | 14.3% | 4 | 19.0% |
Injury, poisoning, and procedural complications | 3 | 14.3% | 2 | 9.5% | 6 | 28.6% |
Investigation | 0 | 0.0% | 1 | 4.8% | 0 | 0.0% |
Metabolism and nutrition disorders | 1 | 4.8% | 0 | 0.0% | 2 | 9.6% |
Musculoskeletal and connective tissue disorders | 2 | 9.6% | 0 | 0.0% | 0 | 0.0% |
Nervous system disorders | 1 | 4.8% | 0 | 0.0% | 1 | 4.8% |
Psychiatric disorders | 0 | 0.0% | 0 | 0.0% | 1 | 4.8% |
Renal and urinary disorders | 2 | 9.6% | 0 | 0.0% | 0 | 0.0% |
Renal and urinary disorders—Investigation | 1 | 4.8% | 0 | 0.0% | 0 | 0.0% |
Respiratory, thoracic, and mediastinal disorders | 2 | 9.5% | 4 | 19.0% | 5 | 23.8% |
Skin and subcutaneous tissue disorders | 1 | 4.8% | 5 | 23.8% | 6 | 28.6% |
Vascular disorders | 1 | 4.8% | 0 | 0.0% | 0 | 0.0% |
Not classified | 2 | 9.5% | 0 | 0.0% | 0 | 0.0% |
