Table 3. All treatment-related toxicities with ≥ 15% incidence according to cohort.
| Cohort(n) | 1 (4) | -1 (1) | 1A (3) | 2 (3) | 3 (7) | Total AEs across all | AEs in cycle 1 | ||
|---|---|---|---|---|---|---|---|---|---|
| Grades | G1/2* G3/4* | G1/2* G3/4* | G1/2* G3/4* | G1/2* G3/4* | G1/2* G3/4* | All grade | ≥ G 3 (%) | All grade | ≥ G 3(%) |
| Anemia | 1 | 2 (11) | 1 (6) | 1 (6) | |||||
| Neutropenia | 1 | 1 | 1 | 4 (22) | 2 (11) | 4 (22) | 1 (6) | ||
| Nausea/vomiting | 2 | 1 | 1 | 1 | 4 | 10 (56) | 1 (6) | 7 (39) | |
| Diarrhea | 2 | 1 | 1 | 2 | 5 | 14 (78) | 3 (17) | 11 (61) | 2 (11) |
|
Elevated AST, ALT or Alk phos |
1 1 |
1 | 1 | 1 | 3 (17) | 1 (6) | 3 (17) | 1 (6) | |
| Fistula | 1 (6) | 1 (6) | |||||||
| Obstruction | 1 | 1 (6) | 1 (6) | ||||||
| Mucositis | 2 | 1 | 1 | 1 | 4 (22) | 3 (17) | |||
| Change in Taste | 2 | 1 | 3 (17) | 1 (6) | |||||
| Dehydration | 1 | 1 | 3 (17) | 1 (6) | 2 (11) | ||||
| Fatigue | 1 | 1 | 1 | 2 | 3 | 10 (56) | 2 (11) | 9 (50) | 2 (11) |
| Anorexia / weight loss | 2# 3 | 1 | 2 | 3 | 9 (50) | 6(33) | |||
| Hypophosphatemia | 1 | 2 | 5 (28) | 2 (11) | 3 (17) | ||||
| Hypomagnesemia | 2 | 4 (22) | 2 (11) | 3 (17) | 1 (6) | ||||
| Hypokalemia | 1 | 1 | 1 | 5 (28) | 3 (17) | 4 (22) | 1 (6) | ||
| Rash | 1 | 1 | 3 | 1 2 | 2 6 | 13 (72) | 12(67) | ||
| Tetany | 1 | 1 (6) | 1 (6) | ||||||
| Pain | 1 | 2 | 3 (17) | 3 (17) | |||||
Toxicities with possible, probable or definite relation to study treatment and graded per NCI CTCAE version 3.
Note: Patients with a recurrent AE counted only once at higher grade for final AE analysis but lower grade cycle 1 AE also denoted above.
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DLTs
Abbreviations: ALT, alanine amino-transferase; AST, aspartate amino-transferase