Table 2.
Study summary and treatment-emergent adverse events (TEAEs)
| Dose level (mg/m2) (N) | 50 (1) | 82.5 (4) | 125 (3) | 175 (6) | 225 (4) | 275 (3) |
|---|---|---|---|---|---|---|
| Administration schedule | ||||||
| No. of patients who received one cycle | 0 | 1 | 2 | 1 | 1 | 1 |
| No. of patients who received two cycles | 1 | 3 | 1 | 3 | 3 | 2 |
| No. of patients who received five cycles | 0 | 0 | 0 | 1 | 0 | 0 |
| No. of patients who received six cycles | 0 | 0 | 0 | 1 | 0 | 0 |
| TEAEsa by Gradeb (patients with at least one event) | ||||||
| Grade 1 | 28 (1) | 43 (4) | 5 (2) | 76 (5) | 24 (3) | 3 (2) |
| Grade 2 | 12 (3) | 7 (3) | 39 (6) | 22 (4) | 16 (3) | |
| Grade 3 | 7 (2) | 6 (3) | 18 (6) | 6 (2) | 14 (3) | |
| Grade 4 | 1 (1) | 2 (1) | ||||
| Grade 5 | 1 (1) | 2 (2) | ||||
| No. of patients with TEAEs deemed possibly, probably or definitely related to study drug administration per adverse eventa | ||||||
| Hemolysis | 1 | |||||
| Abdominal distention | 3 | 3 | 1 | |||
| Abdominal pain | 1 | 3 | 4 | 1 | ||
| Ascites | 3 | |||||
| Constipation | 1 | 2 | 1 | 1 | ||
| Diarrhea | 2 | 1 | ||||
| Dry mouth | 1 | |||||
| Dyspepsia | 1 | 2 | ||||
| Ileus | 1 | |||||
| Nausea | 1 | 1 | 3 | 1 | ||
| Vomiting | 2 | 1 | ||||
| Early satiety | 1 | |||||
| Fatigue | 4 | 3 | 2 | |||
| Implant site effusion | 2 | |||||
| Wound infection | 1 | |||||
| Anastomotic leak | 1 | |||||
| Wound complication | 1 | |||||
| Blood creatinine increased | 1 | |||||
| Decreased appetite | 1 | 2 | 2 | 1 | ||
| Dehydration | 1 | 2 | ||||
| Hypokalemia | 1 | |||||
| Muscular weakness | 1 | |||||
| Myalgia | 1 | |||||
| Dizziness | 1 | |||||
| Insomnia | 1 | |||||
| Pelvic pain | 2 | |||||
| Dyspnea | 3 | |||||
| Alopecia | 1 | |||||
| Acne | 1 | |||||
| Flushing | 2 | |||||
| Off study summary | ||||||
| Patients lost to follow-up | 0 | 0 | 0 | 1 | 0 | 0 |
| Death not related to study drug administration | 0 | 4 | 3 | 3 | 4 | 3 |
a
Adverse events coded with MedDRA Coding Dictionary Version 16.1
b
TEAEs graded according to the NCI Common Terminology Criteria Adverse Events (CTCAE-v3.0)