Table 2.
Treatment-related AEs (any grade) occurring in ≥10% of all patientsa and corresponding number of grade ≥3 AEs
| Preferred term,bn (%) | Arm B (N = 28) |
|
|---|---|---|
| Any grade | Grade ≥ 3 | |
| Patients with any AE, n (%) | 28 (100.0) | 20 (71.4) |
| Nausea | 14 (50.0) | 2 (7.1) |
| Diarrhea | 13 (46.4) | 2 (7.1) |
| Anemia | 10 (35.7) | 2 (7.1) |
| Neutropenia | 10 (35.7) | 10 (35.7) |
| Asthenia | 9 (32.1) | 0 |
| Vomiting | 8 (28.6) | 3 (10.7) |
| Decreased appetite | 6 (21.4) | 0 |
| Dysgeusia | 6 (21.4) | 0 |
| Fatigue | 5 (17.9) | 1 (3.6) |
| Constipation | 4 (14.3) | 0 |
| Dyspepsia | 4 (14.3) | 0 |
| Amylase increased | 3 (10.7) | 1 (3.6) |
| Arthralgia | 3 (10.7) | 0 |
| Muscular weakness | 3 (10.7) | 0 |
| Edema peripheral | 3 (10.7) | 0 |
| Peripheral sensory neuropathy | 3 (10.7) | 0 |
| Weight decreased | 3 (10.7) | 0 |
| White blood cell count decreased | 3 (10.7) | 3 (10.7) |
AE, adverse event.
a
Number (%) of patients in Arm B with AEs, sorted in decreasing frequency by preferred term. Patients with multiple events in the same preferred term were counted only once in that preferred term. Patients with events in >1 preferred term were counted once in each of those preferred terms. Included AEs with an onset or worsen date on or after the date of first dose and up to and including the 30-day and 90-day follow-ups from the date of last dose of study medication.
b
Medical Dictionary for Regulatory Activities Version 24.1.