Table 3.
Clinical adverse events potentially associated with complicated diarrhea (safety population)
| Adverse event, N (%) | Neratinib (N = 1408) | Placebo (N = 1408) | ||||||
|---|---|---|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Nausea | 439 (31.2) | 140 (9.9) | 26 (1.8) | 0 | 269 (19.1) | 32 (2.3) | 2 (0.1) | 0 |
| Vomitinga | 221 (15.7) | 101 (7.2) | 47 (3.3) | 0 | 86 (6.1) | 21 (1.5) | 5 (0.4) | 0 |
| Fatiguea | 256 (18.2) | 103 (7.3) | 23 (1.6) | 0 | 214 (15.2) | 62 (4.4) | 6 (0.4) | 0 |
| Abdominal paina | 232 (16.5) | 82 (5.8) | 24 (1.7) | 0 | 119 (8.5) | 22 (1.6) | 3 (0.2) | 0 |
| Abdominal pain upper | 160 (11.4) | 41 (2.9) | 11 (0.8) | 0 | 85 (6.0) | 8 (0.6) | 3 (0.2) | 0 |
| Decreased appetitea | 136 (9.7) | 30 (2.1) | 3 (0.2) | 0 | 34 (2.4) | 6 (0.4) | 0 | 0 |
| Weight decreased | 44 (3.1) | 23 (1.6) | 1 (0.1) | 0 | 5 (0.4) | 2 (0.1) | 0 | 0 |
| Pyrexia | 66 (4.7) | 13 (0.9) | 0 | 0 | 47 (3.3) | 8 (0.6) | 0 | 0 |
| Dehydration | 12 (0.9) | 26 (1.8) | 12 (0.9) | 1 (0.1) | 2 (0.1) | 2 (0.1) | 1 (0.1) | 0 |
| Neutropenia | 5 (0.4) | 13 (0.9) | 0 | 1 (0.1) | 7 (0.5) | 4 (0.3) | 2 (0.1) | 0 |
| Nephrotoxicity | 13 (0.9) | 5 (0.4) | 7 (0.5) | 1 (0.1) | 4 (0.3) | 2 (0.1) | 0 | 0 |
| Blood creatinine increased | 9 (0.6) | 3 (0.2) | 1 (0.1) | 1 (0.1) | 3 (0.2) | 1 (0.1) | 0 | 0 |
| Blood urea increased | 1 (0.1) | 1 (0.1) | 1 (0.1) | 0 | 0 | 0 | 0 | 0 |
| Glomerular filtration rate decreased | 1 (0.1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Protein urine present | 0 | 0 | 0 | 0 | 0 | 1 (0.1) | 0 | 0 |
| Renal failure | 0 | 1 (0.1) | 3 (0.2) | 0 | 0 | 0 | 0 | 0 |
| Acute renal failure | 1 (0.1) | 1 (0.1) | 3 (0.2) | 0 | 0 | 0 | 0 | 0 |
| Renal function test abnormal | 1 (0.1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Renal impairment | 0 | 0 | 0 | 0 | 1 (0.1) | 0 | 0 | 0 |
| Hypokalemia | 17 (1.2) | 0 | 4 (0.3) | 1 (0.1) | 11 (0.8) | 0 | 5 (0.4) | 0 |
| Hyponatremia | 4 (0.3) | 0 | 5 (0.4) | 0 | 2 (0.1) | 0 | 5 (0.4) | 2 (0.1) |
aMissing grades: vomiting (placebo, n = 1), fatigue (placebo, n = 1), abdominal pain (neratinib, n = 2), and decreased appetite (neratinib, n = 1)