Table 3.
All reproted AEs
| All percents are for the cohort represented in that column | Cohort | All (n = 11) | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Level − 1 (n = 4) | Level 1 (n = 7) | |||||||||||||||||
| Grade | Grade | Grade | ||||||||||||||||
| 2 | 3 | 5 | 2 | 3 | 5 | 2 | 3 | 5 | ||||||||||
| N | % | N | % | N | % | N | % | N | % | N | % | N | % | N | % | N | % | |
| Adverse event | ||||||||||||||||||
| Abdominal pain | 1 | 25 | – | – | – | 0 | 2 | 29 | 1 | 14 | – | 0 | 3 | 27 | 1 | 9 | – | 0 |
| Anorexia | 3 | 75 | – | – | – | 0 | 2 | 29 | – | 0 | – | 0 | 5 | 45 | – | 0 | – | 0 |
| Back pain | 1 | 25 | – | – | – | 0 | 2 | 29 | – | 0 | – | 0 | 3 | 27 | – | 0 | – | 0 |
| Death NOS | – | 0 | – | – | 1 | 25 | – | 0 | – | 0 | – | 0 | – | 0 | – | 0 | 1 | 9 |
| Dehydration | – | 0 | – | – | – | 0 | 3 | 43 | – | 0 | – | 0 | 3 | 27 | – | 0 | – | 0 |
| Diarrhea | 2 | 50 | – | – | – | 0 | 1 | 14 | – | 0 | – | 0 | 3 | 27 | – | 0 | – | 0 |
| Fatigue | 1 | 25 | – | – | – | 0 | 4 | 57 | – | 0 | – | 0 | 5 | 45 | – | 0 | – | 0 |
| Infusion-related reaction | – | 0 | – | – | – | 0 | 2 | 29 | 1 | 14 | – | 0 | 2 | 18 | 1 | 9 | – | 0 |
| Nausea | 2 | 50 | – | – | – | 0 | 1 | 14 | – | 0 | – | 0 | 3 | 27 | – | 0 | – | 0 |
| Palmar-plantar erythrodysesthesia syndrome | 1 | 25 | – | – | – | 0 | 3 | 43 | – | 0 | – | 0 | 4 | 36 | – | 0 | – | 0 |
| Pelvic infection | – | 0 | – | – | – | 0 | – | 0 | – | 0 | 1 | 14 | – | 0 | – | 0 | 1 | 9 |