TABLE 3.
Number of treatment emergent adverse events (number of patients, % of patients) classified by MedDRA System Organ Class and preferred term, and investigator‐assigned relationship to study drug
| Cohort 1, 225 mg (N = 6) | Cohort 2, 600 mg (N = 6) | |||
|---|---|---|---|---|
| Related to drug administration | Not related to drug administration | Related to drug administration | Not related to drug administration | |
| Ear and labyrinth disorder | … | … | … | 1 (1, 17%) |
| Ear pain | … | … | … | 1 (1, 17%) |
| Gastrointestinal disorders | 2 (2, 33%) | 1 (1, 17%) | … | … |
| Diarrhoea | 2 (2, 33%) | 1 (1, 17%) | … | … |
| General disorders and administration site conditions | … | 1 (1, 17%) | … | … |
| Alcoholic hangover | … | 1 (1, 17%) | … | … |
| Investigations | 3 (2, 33%) | … | … | … |
| Alanine aminotransferase increased | 1 (1, 17%) | … | … | … |
| Aspartate aminotransferase increased | 1 (1, 17%) | … | … | … |
| Blood bilirubin increased | 1 (1, 17%) | … | … | … |
| Metabolism and nutrition disorders | … | 1 (1, 17%) | … | … |
| Hypophosphatemia | … | 1 (1, 17%) | … | … |
| Musculoskeletal and connective tissue disorders | … | 2 (2, 33%) | … | … |
| Back pain | … | 1 (1, 17%) | … | … |
| Myalgia | … | 1 (1, 17%) | … | … |
| Nervous system disorders | … | … | … | 4 (3, 50%) |
| Headache | … | … | … | 4 (3, 50%) |
| Respiratory, thoracic, and mediastinal disorders | … | … | … | 1 (1, 17%) |
| Cough | … | … | … | 1 (1, 17%) |