Table 5.
Toxicity.
| Glembatumumab vedotin | Capecitabine | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (n = 213) | (n = 92) | ||||||||||||||
| Grade 1–2 | Grade 3 | Grade 4 | Grade 5 | Grade 1–2 | Grade 3 | Grade 4 | Grade 5 | ||||||||
| Any adverse event | 61 | (29%) | 114 | (54%) | 32 | (15%) | 4 | (2%) | 40 | (44%) | 44 | (48%) | 8 | (9%) | 0 |
| Fatigue | 91 | (43%) | 11 | (5%) | 0 | 0 | 33 | (36%) | 6 | (7%) | 0 | (0%) | 0 | ||
| Nausea | 87 | (41%) | 7 | (3%) | 0 | 0 | 37 | (40%) | 2 | (2%) | 1 | (1%) | 0 | ||
| Rash* | 69 | (32%) | 26 | (12%) | 0 | 0 | 9 | (10%) | 1 | (1%) | 0 | (0%) | 0 | ||
| Alopecia | 88 | (41%) | 0 | 0 | 0 | 1 | (1%) | 0 | 0 | 0 | |||||
| Neutropenia* | 25 | (12%) | 38 | (18%) | 21 | (10%) | 0 | 4 | (4%) | 2 | (2%) | 1 | (1%) | 0 | |
| Pruritus* | 70 | (33%) | 9 | (4%) | 0 | 0 | 4 | (4%) | 0 | 0 | 0 | ||||
| Peripheral neuropathy* | 67 | (32%) | 10 | (5%) | 0 | 0 | 9 | (10%) | 0 | 1 | (1%) | 0 | |||
| Decreased appetite | 63 | (30%) | 1 | (1%) | 0 | 0 | 15 | (16%) | 2 | (2%) | 0 | 0 | |||
| Constipation | 56 | (26%) | 6 | (3%) | 0 | 0 | 13 | (14%) | 0 | (0%) | 0 | 0 | |||
| Diarrhea | 52 | (24%) | 7 | (3%) | 0 | 0 | 32 | (35%) | 12 | (13%) | 1 | (1%) | 0 | ||
| Vomiting | 44 | (21%) | 6 | (3%) | 0 | 0 | 16 | (17%) | 3 | (3%) | 1 | (1%) | 0 | ||
| Abdominal pain* | 34 | (16%) | 10 | (5%) | 0 | 0 | 19 | (21%) | 3 | (3%) | 0 | 0 | |||
| Pyrexia* | 42 | (20%) | 1 | (1%) | 0 | 0 | 12 | (13%) | 0 | 0 | 0 | ||||
| Stomatitis | 30 | (14%) | 7 | (3%) | 1 | (1%) | 0 | 19 | (21%) | 5 | (5%) | 0 | 0 | ||
| Dyspnea | 26 | (12%) | 9 | (4%) | 1 | (1%) | 0 | 10 | (11%) | 1 | (1%) | 0 | 0 | ||
| Anemia* | 29 | (14%) | 7 | (3%) | 0 | 0 | 7 | (8%) | 3 | (3%) | 0 | 0 | |||
| Leukopenia* | 14 | (7%) | 16 | (8%) | 4 | (2%) | 0 | 3 | (3%) | 0 | (0%) | 0 | 0 | ||
| Hypokalemia* | 22 | (10%) | 6 | (3%) | 0 | 0 | 5 | (5%) | 0 | 4 | (4%) | 0 | |||
| Aspartate transferase increased | 16 | (7%) | 8 | (4%) | 1 | (1%) | 0 | 5 | (5%) | 1 | (1%) | 0 | 0 | ||
| Pain | 16 | (8%) | 7 | (3%) | 0 | 0 | 3 | (3%) | 1 | (1%) | 0 | 0 | |||
| Alanine aminotransferase increased | 19 | (9%) | 4 | (2%) | 0 | 0 | 1 | (1%) | 2 | (2%) | 0 | 0 | |||
| Lymphopenia* | 9 | (4%) | 8 | (4%) | 2 | (1%) | 0 | 1 | (1%) | 5 | (5%) | 0 | 0 | ||
| Dehydration | 9 | (4%) | 8 | (4%) | 1 | (1%) | 0 | 6 | (7%) | 1 | (1%) | 0 | 0 | ||
| Blood alkaline phosphatase increased | 10 | (5%) | 8 | (4%) | 0 | 0 | 2 | (2%) | 0 | 0 | 0 | ||||
| Hypophosphatemia* | 8 | (4%) | 6 | (3%) | 1 | (1%) | 0 | 2 | (2%) | 2 | (2%) | 1 | (1%) | 0 | |
| Palmar-plantar erythrodysesthesia syndrome | 9 | (4%) | 2 | (1%) | 0 | 0 | 33 | (36%) | 7 | (8%) | 0 | 0 | |||
| Sepsis syndrome* | 0 | 0 | 3 | (1%) | 4 | (2%) | 0 | 0 | 1 | (1%) | 0 | ||||
| Pulmonary embolism | 0 | 2 | (1%) | 1 | (1%) | 0 | 0 | 4 | (4%) | 0 | 0 | ||||
Data are presented for the safety population (all patients who received at least one dose of study treatment). Table shows all grade 1–2 events occurring in ≥20% of patients in either group and any grade 3–5 event occurring in ≥6 patients overall. Four patients died due to adverse events, all on the glembatumumab vedotin arm. Overall, 199 deaths were reported, 173 (87%) were owing to progressive disease (118 of the 134 reported deaths in the glembatumumab vedotin arm and 55 of the 65 reported deaths in the capecitabine arm), 22 were owing to unknown/other cause (12 in the glembatumumab vedotin arm and 10 in the capecitabine arm), and 4 due to adverse event (all on the glembatumumab vedotin arm).
*AE terms that were synonymous were combined.