Table 2.
Adverse events and adverse drug reactions
| Placebo | 50 mg anamorelin | 100 mg anamorelin | |
|---|---|---|---|
| n | 58 | 65 | 55 |
| Adverse events | 58 (100.0) | 61 (93.8) | 53 (96.4) |
| Difference (%) vs. placebo (95 % CI) | −6.2 (−12.0, −0.3) | −3.6 (−8.6, 1.3) | |
| P value | 0.0548 | 0.1428 | |
| Serious adverse events | 29 (50.0) | 26 (40.0) | 17 (30.9) |
| Discontinuations due to adverse events | 6 (10.3) | 14 (21.5) | 13 (23.6) |
| Adverse drug reactions | 12 (20.7) | 25 (38.5) | 29 (52.7) |
| Difference (%) vs. placebo (95 % CI) | 17.8 (2.0, 33.5) | 32.0 (15.2, 48.9) | |
| P value | 0.0319 | 0.0004 | |
| Serious adverse drug reactions | 4 (6.9) | 3 (4.6) | 0 (0.0) |
| Discontinuations due to adverse drug reactions | 2 (3.4) | 4 (6.2) | 5 (9.1) |
| Deaths | 12 (20.7) | 8 (12.3) | 6 (10.9) |
| Adverse events by grade | |||
| Grade 3 | 17 (29.3) | 23 (35.4) | 15 (27.3) |
| Grade 4 | 13 (22.4) | 9 (13.8) | 11 (20.0) |
| Grade 5 | 13 (22.4) | 11 (16.9) | 7 (12.7) |
| Adverse events in ≥20 % of patients in either anamorelin group | |||
| White blood cell count decreased | 18 (31.0) | 20 (30.8) | 14 (25.5) |
| Neutrophil count decreased | 15 (25.9) | 19 (29.2) | 13 (23.6) |
| CRP increased | 19 (32.8) | 16 (24.6) | 10 (18.2) |
| Hemoglobin decreased | 15 (25.9) | 14 (21.5) | 11 (20.0) |
| Nausea | 10 (17.2) | 9 (13.8) | 17 (30.9) |
| Vomiting | 10 (17.2) | 14 (21.5) | 6 (10.9) |
| Glycosylated hemoglobin increased | 0 (0) | 4 (6.2) | 11 (20.0) |
Values are expressed as the n (%) of patients
CI confidence interval