Table 2.
Summary of treatment-emergent adverse events
| AEs,a n (%) | Placebo + gemcitabine (n = 317) |
Ganitumab 12 mg/kg + gemcitabine (n = 315) |
Ganitumab 20 mg/kg + gemcitabine (n = 160) |
||||||
|---|---|---|---|---|---|---|---|---|---|
| All grades | Grade 3 | Grade 4 | All grades | Grade 3 | Grade 4 | All grades | Grade 3 | Grade 4 | |
| Anyb | 312 (98) | 123 (39) | 53 (17) | 308 (98) | 155 (49) | 59 (19) | 159 (99) | 78 (49) | 16 (10) |
| Nausea | 128 (40) | 7 (2) | 1 (<1) | 133 (42) | 5 (2) | 0 (0) | 71 (44) | 2 (1) | 0 (0) |
| Neutropenia | 109 (34) | 51 (16) | 14 (4) | 117 (37) | 54 (17) | 20 (6) | 52 (33) | 26 (16) | 5 (3) |
| Thrombocytopenia | 94 (30) | 16 (5) | 5 (2) | 126 (40) | 23 (7) | 4 (1) | 54 (34) | 8 (5) | 4 (3) |
| Fatigue | 93 (29) | 12 (4) | 0 (0) | 111 (35) | 15 (5) | 4 (1) | 62 (39) | 8 (5) | 0 (0) |
| Decreased appetite | 85 (27) | 5 (2) | 0 (0) | 94 (30) | 7 (2) | 1 (<1) | 37 (23) | 0 (0) | 0 (0) |
| Vomiting | 72 (23) | 11 (3) | 1 (<1) | 89 (28) | 12 (4) | 2 (1) | 46 (29) | 3 (2) | 0 (0) |
| Pyrexia | 69 (22) | 2 (1) | 0 (0) | 67 (21) | 1 (<1) | 2 (1) | 43 (27) | 1 (1) | 0 (0) |
| Anemia | 76 (24) | 19 (6) | 1 (<1) | 64 (20) | 10 (3) | 3 (1) | 36 (23) | 4 (3) | 1 (1) |
| Constipation | 62 (20) | 2 (1) | 0 (0) | 82 (26) | 3 (1) | 0 (0) | 29 (18) | 2 (1) | 0 (0) |
| Diarrhea | 58 (18) | 1 (<1) | 0 (0) | 84 (27) | 3 (1) | 0 (0) | 27 (17) | 2 (1) | 0 (0) |
| Abdominal pain | 59 (19) | 3 (1) | 1 (<1) | 69 (22) | 19 (6) | 0 (0) | 27 (17) | 3 (2) | 0 (0) |
| Hyperglycemia | 31 (10) | 7 (2) | 0 (0) | 63 (20) | 33 (10) | 4 (1) | 42 (26) | 23 (14) | 4 (3) |
| Peripheral edema | 58 (18) | 7 (2) | 0 (0) | 49 (16) | 1 (<1) | 0 (0) | 25 (16) | 1 (1) | 0 (0) |
| Alanine aminotransferase increased | 45 (14) | 1 (<1) | 0 (0) | 61 (19) | 0 (0) | 0 (0) | 24 (15) | 0 (0) | 0 (0) |
| Aspartate aminotransferase increased | 40 (13) | 6 (2) | 2 (1) | 56 (18) | 23 (7) | 1 (<1) | 21 (13) | 7 (4) | 0 (0) |
| Asthenia | 45 (14) | 10 (3) | 0 (0) | 47 (15) | 10 (3) | 2 (1) | 18 (11) | 4 (3) | 0 (0) |
| Rash | 34 (11) | 0 (0) | 0 (0) | 44 (14) | 1 (<1) | 0 (0) | 24 (15) | 1 (1) | 0 (0) |
| Leukopenia | 32 (10) | 9 (3) | 0 (0) | 47 (15) | 14 (4) | 1 (<1) | 15 (9) | 4 (3) | 0 (0) |
| Weight decreased | 29 (9) | 1 (<1) | 0 (0) | 27 (9) | 2 (1) | 0 (0) | 23 (14) | 1 (1) | 0 (0) |
| Fatal AEs | 33 (10) | 30 (10) | 18 (11) | ||||||
AE, adverse event; FOLFIRI, leucovorin, 5-fluorouracil, and irinotecan.
aSafety analysis set. Includes adverse events occurring during treatment and up to 30 days from the last dose of investigational product. Adverse events were coded using MedDRA (v 15.0) and graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.
bOccurring in ≥10% of all patients.