Table 7.
Summary of adverse events (safety population)
| Placebo (n=52) |
Enobosarm 1 mg (n=53) |
Enobosarm 3 mg (n=54) |
||||
|---|---|---|---|---|---|---|
| Grade 1–2 | Grade 3–4 | Grade 1–2 | Grade 3–4 | Grade 1–2 | Grade 3–4 | |
| Abdominal pain | 3 (6%) | 0 | 2 (4%) | 0 | 8 (15%) | 0 |
| Anaemia | 6 (12%) | 2 (4%) | 9 (17%) | 4 (8%) | 5 (9%) | 2 (4%) |
| Anorexia | 2 (4%) | 0 | 4 (8%) | 0 | 6 (11%) | 0 |
| Asthenia | 4 (8%) | 0 | 1 (2%) | 0 | 7 (13%) | 0 |
| Back pain | 3 (6%) | 0 | 5 (9%) | 0 | 1 (2%) | 0 |
| Constipation | 2 (4%) | 0 | 9 (17%) | 0 | 6 (11%) | 0 |
| Cough | 6 (12%) | 0 | 2 (4%) | 0 | 9 (17%) | 0 |
| Dehydration | 3 (6%) | 3 (6%) | 1 (2%) | 0 | 7 (13%) | 0 |
| Diarrhoea | 4 (8%) | 0 | 8 (15%) | 0 | 9 (17%) | 0 |
| Dyspnoea | 5 (10%) | 0 | 6 (11%) | 0 | 3 (6%) | 0 |
| Fatigue | 11 (21%) | 0 | 8 (15%) | 0 | 11 (20%) | 3 (6%) |
| Febrile neutropenia | 0 | 3 (6%) | 0 | 0 | 0 | 0 |
| Headache | 1 (2%) | 0 | 3 (6%) | 0 | 3 (6%) | 0 |
| Malignant neoplasm progression | 0 | 8 (15%) | 0 | 5 (9%) | 0 | 7 (13%) |
| Nausea | 7 (13%) | 0 | 12 (23%) | 0 | 6 (11%) | 0 |
| Neutropenia | 2 (4%) | 0 | 1 (2%) | 0 | 4 (7%) | 0 |
| Pneumonia | 1 (2%) | 0 | 1 (2%) | 0 | 4 (7%) | 0 |
| Pyrexia | 2 (4%) | 0 | 5 (9%) | 0 | 8 (15%) | 0 |
| Thrombocytopenia | 0 | 3 (6%) | 3 (6%) | 1 (2%) | 4 (7%) | 1 (2%) |
| Vomiting | 6 (12%) | 0 | 8 (15%) | 0 | 4 (7%) | 0 |
| Weight decreased | 5 (10%) | 0 | 3 (6%) | 0 | 8 (15%) | 0 |
Data are n (%). Adverse event occurring in >5% of patients in any treatment group. Severity criteria: 0=no adverse event or within normal limits; 1=mild adverse event (minor; no specific medical intervention; asymptomatic laboratory findings only, radiographic findings only; marginal clinical relevance); 2=moderate adverse event (minimal intervention; local intervention; non-invasive intervention [packing, cautery]); 3=severe and undesirable adverse event (significant symptoms requiring admission to hospital or invasive intervention; transfusion; elective interventional radiological procedure; therapeutic endoscopy or operation); 4=life-threatening or disabling adverse event (complicated by acute, life-threatening metabolic or cardiovascular complications, such as circulatory failure, haemorrhage, sepsis; life-threatening physiologic consequences; need for intensive care or emergent invasive procedure; emergent interventional radiological procedure, therapeutic endoscopy or operation); and 5=fatal adverse event.