Table 3.
Any-grade treatment-related AEs and serious AEs (safety population)
| AE, n (%) | Idasa-C (n = 284) |
Placebo-C (n = 146) |
|---|---|---|
| Any-grade treatment-related AEs (≥5% incidence in any arm) | ||
| Diarrhea | 226 (79.6) | 24 (16.4) |
| Nausea | 125 (44.0) | 22 (15.1) |
| Febrile neutropenia | 91 (32.0) | 44 (30.1) |
| Thrombocytopenia | 83 (29.2) | 40 (27.4) |
| Vomiting | 70 (24.6) | 9 (6.2) |
| Anemia | 57 (20.1) | 28 (19.2) |
| Pyrexia | 44 (15.5) | 15 (10.3) |
| Hypokalemia | 41 (14.4) | 9 (6.2) |
| Decreased appetite | 34 (12.0) | 8 (5.5) |
| Hyperbilirubinemia | 34 (12.0) | 5 (3.4) |
| Mucosal inflammation | 31 (10.9) | 7 (4.8) |
| Rash | 31 (10.9) | 15 (10.3) |
| Neutropenia | 30 (10.6) | 12 (8.2) |
| Erythema | 25 (8.8) | 3 (2.1) |
| Abdominal pain | 23 (8.1) | 4 (2.7) |
| Asthenia | 23 (8.1) | 6 (4.1) |
| Fatigue | 18 (6.3) | 5 (3.4) |
| Sepsis | 17 (6.0) | 3 (2.1) |
| Headache | 17 (6.0) | 8 (5.5) |
| Stomatitis | 15 (5.3) | 3 (2.1) |
| Pneumonia | 13 (4.6) | 9 (6.2) |
| Constipation | 8 (2.8) | 10 (6.8) |
| Epistaxis | 8 (2.8) | 11 (7.5) |
| Serious AEs (>2% in system organ class or >5% in preferred term) | ||
| Infections and infestations | 97 (34.2) | 33 (22.6) |
| Sepsis (PT) | 32 (11.3) | 7 (4.8) |
| Pneumonia (PT) | 18 (6.3) | 13 (8.9) |
| Septic shock (PT) | 9 (3.2) | 8 (5.5) |
| Blood and lymphatic system disorders | 37 (13.0) | 14 (9.6) |
| Febrile neutropenia (PT) | 27 (9.5) | 13 (8.9) |
| General disorders and administration site conditions | 18 (6.3) | 5 (3.4) |
| Gastrointestinal disorders | 20 (7.0) | 2 (1.4) |
| Nervous system disorders | 16 (5.6) | 4 (2.7) |
| Hepatobiliary disorders | 12 (4.2) | 3 (2.1) |
| Respiratory, thoracic, and mediastinal disorders | 10 (3.5) | 5 (3.4) |
| Immune system disorders | 10 (3.5) | 4 (2.7) |
| Cardiac disorders | 7 (2.5) | 4 (2.7) |
| Vascular disorders | 7 (2.5) | 1 (0.7) |
| Renal and urinary disorders | 6 (2.1) | 1 (0.7) |
| Injury, poisoning, and procedural complications | 3 (1.1) | 3 (2.1) |
PT, preferred term.