Table 4.
Grade ≥3 TEAE reported for ≥5% of patients in any treatment groupa
| n (%) | Asia region safety population | Overall safety population | ||||||
|---|---|---|---|---|---|---|---|---|
| Combination therapy | Monotherapy | Combination therapy | Monotherapy | |||||
|
nal‐IRI+ 5‐FU/LV n = 33 |
5‐FU/LV n = 29 |
nal‐IRI n = 50 |
5‐FU/LV n = 42 |
nal‐IRI+ 5‐FU/LV n = 117 |
5‐FU/LV n = 105 |
nal‐IRI n = 147 |
5‐FU/LV n = 134 |
|
| Any grade ≥3 TEAE | 29 (87.9) | 17 (58.6) | 34 (68.0) | 23 (54.8) | 90 (76.9) | 60 (57.1) | 112 (76.2) | 75 (56.0) |
| Neutropeniab | 18 (54.5) | 1 (3.4) | 17 (34.0) | 1 (2.4) | 32 (27.4) | 2 (1.9) | 22 (15.0) | 2 (1.5) |
| Anemia | 7 (21.2) | 2 (6.9) | 12 (24.0) | 6 (14.3) | 11 (9.4) | 5 (4.8) | 16 (10.9) | 9 (6.7) |
| WBC count decreased | 7 (21.2) | 0 | 4 (8.0) | 0 | 9 (7.7) | 0 | 4 (2.7) | 0 |
| Asthenia | 4 (12.1) | 3 (10.3) | 3 (6.0) | 5 (11.9) | 9 (7.7) | 6 (5.7) | 10 (6.8) | 9 (6.7) |
| Biliary tract infection | 3 (9.1) | 0 | 1 (2.0) | 1 (2.4) | 3 (2.6) | 1 (1.0) | 1 (0.7) | 2 (1.5) |
| Abdominal pain | 2 (6.1) | 0 | 5 (10.0) | 1 (2.4) | 8 (6.8) | 6 (5.7) | 12 (8.2) | 8 (6.0) |
| Decreased appetite | 2 (6.1) | 1 (3.4) | 6 (12.0) | 2 (4.8) | 5 (4.3) | 2 (1.9) | 13 (8.8) | 3 (2.2) |
| Nausea | 2 (6.1) | 0 | 3 (6.0) | 1 (2.4) | 9 (7.7) | 2 (1.9) | 8 (5.4) | 4 (3.0) |
| Sepsis | 2 (6.1) | 0 | 1 (2.0) | 0 | 4 (3.4) | 1 (1.0) | 3 (2.0) | 1 (0.7) |
| Vomiting | 2 (6.1) | 0 | 6 (12.0) | 0 | 13 (11.1) | 3 (2.9) | 20 (13.6) | 4 (3.0) |
| Diarrhea | 1 (3.0) | 2 (6.9) | 8 (16.0) | 2 (4.8) | 15 (12.8) | 6 (5.7) | 31 (21.1) | 6 (4.5) |
| Febrile neutropenia | 1 (3.0) | 0 | 5 (10.0) | 0 | 2 (1.7) | 0 | 6 (4.1) | 0 |
| Hyponatremia | 1 (3.0) | 0 | 3 (6.0) | 0 | 3 (2.6) | 2 (1.9) | 9 (6.1) | 2 (1.5) |
| Fatigue | 0 | 0 | 3 (6.0) | 1 (2.4) | 16 (13.7) | 4 (3.8) | 9 (6.1) | 5 (3.7) |
| Hydronephrosis | 0 | 2 (6.9) | 0 | 2 (4.8) | 0 | 2 (1.9) | 0 | 2 (1.5) |
| Hyperglycemia | 0 | 0 | 4 (8.0) | 1 (2.4) | 1 (0.9) | 2 (1.9) | 8 (5.4) | 3 (2.2) |
| Hypokalemia | 0 | 1 (3.4) | 7 (14.0) | 2 (4.8) | 4 (3.4) | 2 (1.9) | 17 (11.6) | 3 (2.2) |
| Leukopenia | 0 | 0 | 3 (6.0) | 0 | 1 (0.9) | 0 | 4 (2.7) | 0 |
Abbreviations: 5‐FU, 5‐fluorouracil; LV, leucovorin (folinic acid); nal‐IRI, liposomal irinotecan; n/a, not applicable; SD, standard deviation; WBC, white blood cell.
Patients with multiple occurrences are counted only once in any category. Safety population included patients who received at least one dose of study drug. Adverse events coded using MedDRA version 14.1. Treatment emergent adverse events (TEAE) are events that occurred or worsened on or after the day of first dose of the study drug and within 30 d after last administration of study drug.
Based on summary term comprising agranulocytosis, decreased neutrophil count, febrile neutropenia, granulocytopenia, neutropenia, neutropenic sepsis, and pancytopenia.