TABLE 3.
Frequency of AEs and ADRs, and AEs by SOC and preferred term in Parts A, B, C, D, and E combined (safety analysis set)
| Napabucasin (mg) |
Pooled placebo (N = 14) |
|||||||
|---|---|---|---|---|---|---|---|---|
|
80 mg (N = 1) |
160 mg (N = 1) |
240 mg (N = 15) |
480 mg (N = 15) |
720 mg (N = 15) |
1200 mg (N = 9) |
480 mg fed (N = 6) |
||
| AEs, n (%) [number of events] | 0 | 0 | 12 (80.0) [31] | 12 (80.0) [26] | 15 (100.0) [35] | 9 (100.0) [23] | 5 (83.3) [11] | 1 (7.1) [1] |
| AEs leading to death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Serious AEs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| ADRs, n (%) [number of events] | 0 | 0 | 11 (73.3) [18] | 12 (80.0) [25] | 15 (100.0) [35] | 9 (100.0) [21] | 4 (66.7) [4] | 1 (7.1) [1] |
| ADRs leading to death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Serious ADRs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| AE—SOC, n (%) | ||||||||
| Cardiac disorders | – | – | 2 (13.3) | – | – | – | – | – |
| Atrioventricular block first degree | 1 (6.7) | |||||||
| Sinus bradycardia | 1 (6.7) | |||||||
| Gastrointestinal disorders | – | – | 10 (66.7) | 12 (80.0) | 15 (100.0) | 9 (100.0) | 5 (83.3) | 1 (7.1) |
| Diarrhea | 7 (46.7) | 11 (73.3) | 14 (93.3) | 8 (88.9) | – | 1 (7.1) | ||
| Abdominal pain | 7 (46.7) | 9 (60.0) | 8 (53.3) | 5 (55.6) | 4 (66.7) | – | ||
| Nausea | 1 (6.7) | 1 (6.7) | 4 (26.7) | 1 (11.1) | – | – | ||
| Abdominal distension | – | – | – | 1 (11.1) | – | – | ||
| Gingival pain | – | – | – | – | 1 (16.7) | – | ||
| General disorders/administration site conditions | – | – | – | – | 1 (6.7) | 1 (11.1) | 1 (16.7) | – |
| Application site erythema | – | – | 1 (16.7) | |||||
| Application site pruritus | – | 1 (11.1) | – | |||||
| Malaise | – | 1 (11.1) | – | |||||
| Pyrexia | 1 (6.7) | – | – | |||||
| Investigations | – | – | 1 (6.7) | – | – | – | 1 (16.7) | – |
| Blood creatine phosphokinase increased | 1 (6.7) | – | ||||||
| Lymphocyte count decreased | – | 1 (16.7) | ||||||
| Monocyte count increased | – | 1 (16.7) | ||||||
| Neutrophil count increased | – | 1 (16.7) | ||||||
| White blood cell count increased | – | 1 (16.7) | ||||||
| Nervous system disorders | – | – | – | – | 2 (13.3) | 1 (11.1) | – | – |
| Presyncope | 1 (6.7) | 1 (11.1) | ||||||
| Headache | 1 (6.7) | – | ||||||
| Renal and urinary disorders | – | – | 3 (20.0) | 3 (20.0) | 4 (26.7) | 5 (55.6) | – | – |
| Chromaturia | 3 (20.0) | 3 (20.0) | 4 (26.7) | 5 (55.6) | ||||
| Vascular disorders | – | – | – | 1 (6.7) | 1 (6.7) | – | 1 (16.7) | – |
| Hypertension | 1 (6.7) | – | 1 (16.7) | |||||
| Hot flush | – | 1 (6.7) | – | |||||
Abbreviations: ADR, adverse drug reaction; AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities; SOC, system organ class.
AEs coded according to MedDRA v19.1.