Table 2.
Summary of safety data (SAS).
| n, % | Zapnometinib arm (n = 51) | Placebo arm (n = 52) | Total (n = 103) |
|---|---|---|---|
| Any TEAEs | 20 (39.2) | 18 (34.6) | 38 (36.9) |
| TEAEs occurring in >5% of either arm | |||
| ALT increased | 3 (5.9) | 1 (1.9) | 4 (3.9) |
| Diarrhoea | 4 (7.8) | 3 (5.8) | 7 (6.8) |
| Dyspnoea | 1 (2.0) | 3 (5.8) | 4 (3.9) |
| Cough | 0 | 3 (5.8) | 3 (2.9) |
| Headache | 0 | 3 (5.8) | 3 (2.9) |
| Any severe TEAE | 2 (3.9) | 5 (9.6) | 7 (6.8) |
| Severe TEAEs occurring in >5% of either arm | |||
| Dyspnoea | 0 | 3 (5.8) | 3 (2.9) |
| Any serious TEAE | 3 (5.9) | 4 (7.7) | 7 (6.8) |
| Serious TEAEs occurring in >5% of either arm | |||
| None | 0 | 0 | 0 |
| Any TEAE leading to discontinuation of IMP | 1 (2.0) | 0 | 1 (1.0) |
| Any TEAE leading to withdrawal from trial | 1 (2.0) | 2 (3.8) | 3 (2.9) |
| Any ADR | 11 (21.6) | 8 (15.4) | 19 (18.4) |
| ADRs occurring in >5% of either am | |||
| ALT increased | 3 (5.9) | 1 (1.9) | 4 (3.9) |
| Diarrhoea | 3 (5.9) | 1 (1.9) | 4 (3.9) |
| Any severe ADR | 1 (2.0) | 0 | 1 (1.0) |
| Any serious ADR | 2 (3.9) | 0 | 2 (1.9) |
| Death | 1 (2.0) | 2 (3.8) | 3 (2.9) |
ADR, adverse drug reaction (an AE judged to be at least possibly related to zapnometinib or placebo); ALT, alanine aminotransferase; SAS, safety analysis set; (TE)AE, (treatment-emergent) adverse event.