Table 4:
Non-laboratory Adverse Reactions (≥ 10%) in the Pooled Safety Populationa
|
Preferred termb |
DEC-C Cycle 1 (n = 107) |
IV Decitabine Cycle 1 (n = 106) |
DEC-C All Cycles (n = 208) |
|||
|---|---|---|---|---|---|---|
| Any Grade | Grade 3–4 | Any Grade | Grade 3–4 | Any Grade | Grade 3–4 | |
| Fatigue | 29% | 2% | 25% | 0 | 55% | 5% |
| Constipation | 20% | 0 | 23% | 0 | 44% | 0 |
| Hemorrhage | 24% | 2% | 17% | 0% | 43% | 3% |
| Myalgia | 9% | 2% | 16% | 1% | 42% | 3% |
| Mucositis | 18% | 1% | 24% | 2% | 41% | 4% |
| Arthralgia | 9% | 1% | 13% | 1% | 40% | 3% |
| Nausea | 25% | 0 | 16% | 0 | 40% | 0.5% |
| Dyspnea | 17% | 3% | 9% | 3% | 38% | 6% |
| Diarrhea | 16% | 0 | 11% | 0 | 37% | 1% |
| Rash | 12% | 1% | 11% | 1% | 33% | 0.5% |
| Febrile neutropenia | 10% | 10% | 13% | 13% | 33% | 32% |
| Dizziness | 16% | 1% | 11% | 0 | 33% | 2% |
| Edema | 10% | 0 | 11% | 0 | 30% | 0.5% |
| Cough | 7% | 0 | 8% | 0 | 28% | 0 |
| Headache | 22% | 0 | 13% | 0 | 30% | 0 |
| Decreased appetite | 10% | 1% | 6% | 0 | 24% | 2% |
| URI | 6% | 0 | 3% | 0 | 23% | 1% |
| Pneumonia | 7% | 7% | 7% | 5% | 21% | 15% |
| Transaminase increased | 12% | 1% | 3% | 0 | 21% | 3% |
| Abdominal pain | 9% | 0 | 7% | 0 | 19% | 1% |
| Pyrexia | 7% | 0 | 7% | 0 | 19% | 1% |
| Renal impairment | 9% | 0 | 8% | 1% | 18% | 0 |
| Vomiting | 5% | 0 | 5% | 0 | 15% | 0 |
| Sepsis | 6% | 6% | 2% | 1% | 14% | 11% |
| Neuropathy | 4% | 0 | 8% | 0 | 13% | 0 |
| Fall | 4% | 0 | 1% | 0 | 12% | 1% |
| Insomnia | 6% | 0 | 2% | 0 | 12% | 0.5% |
| Cellulitis | 4% | 1% | 3% | 2% | 12% | 5% |
| Hypotension | 4% | 0 | 6% | 1% | 11% | 2% |
| Arrhythmia | 3% | 0 | 2% | 0 | 11% | 1% |
| Weight decreased | 5% | 0 | 3% | 0 | 10% | 1% |
Abbreviations: DEC-C, oral decitabine and cedazuridine; URI, upper respiratory tract infection
a
Adapted from Otsuka INQOVI (decitabine and cedazuridine tablets) [drug label] (12).
b
Includes grouped terms. See Supplementary Table S2 for further information.