Table 3.
Summary of TEAEs (incidence: ≥ 10%) in the safety analysis set
| Total number of TEAEs | 783 | ||
|---|---|---|---|
| Patients who had at least one TEAE (any causality), n (%) | 38 (100.0) | ||
| TEAEs—grade ≥ 3, n (%) | 38 (100.0) | ||
| Serious TEAEs, n (%) | 13 (34.2) | ||
| TEAEs that led to treatment discontinuation, n (%) | 17 (44.7) | ||
| Common TEAEs | All grades | Grade 3 | Grade 4 |
| Hematologic, n (%) | 38 (100.0) | ||
| Lymphocyte count decreased | 34 (89.5) | 3 (7.9) | 31 (81.6) |
| Neutrophil count decreased | 31 (81.6) | 18 (47.4) | 10 (26.3) |
| White blood cell count decreased | 31 (81.6) | 22 (57.9) | 3 (7.9) |
| CD4 lymphocytes decreased | 25 (65.8) | 5 (13.2) | 20 (52.6) |
| Platelet count decreased | 25 (65.8) | 3 (7.9) | 5 (13.2) |
| Anemia | 8 (21.1) | 3 (7.9) | 0 (0.0) |
| Febrile neutropenia | 4 (10.5) | 4 (10.5) | 0 (0.0) |
| Hemoglobin decreased | 4 (10.5) | 0 (0.0) | 0 (0.0) |
| Nonhematologic, n (%) | 37 (97.4) | ||
| Infusion-related reaction | 13 (34.2) | 0 (0.0) | 0 (0.0) |
| Pyrexia | 12 (31.6) | 1 (2.6) | 0 (0.0) |
| IgM decreased | 12 (31.6) | 0 (0.0) | 0 (0.0) |
| IgG decreased | 10 (26.3) | 0 (0.0) | 0 (0.0) |
| Constipation | 10 (26.3) | 0 (0.0) | 0 (0.0) |
| Nausea | 10 (26.3) | 0 (0.0) | 0 (0.0) |
| Decreased appetite | 9 (23.7) | 2 (5.3) | 0 (0.0) |
| AST increased | 9 (23.7) | 0 (0.0) | 0 (0.0) |
| Malaise | 9 (23.7) | 0 (0.0) | 0 (0.0) |
| ALT increased | 7 (18.4) | 0 (0.0) | 0 (0.0) |
| Hepatic function abnormal | 6 (15.8) | 0 (0.0) | 1 (2.6) |
| γ-GTP increased | 6 (15.8) | 1 (2.6) | 0 (0.0) |
| Rash | 6 (15.8) | 1 (2.6) | 0 (0.0) |
| Vomiting | 6 (15.8) | 0 (0.0) | 0 (0.0) |
| IgA decreased | 6 (15.8) | 0 (0.0) | 0 (0.0) |
| Hyperkalemia | 6 (15.8) | 0 (0.0) | 0 (0.0) |
| Renal impairment | 5 (13.2) | 0 (0.0) | 1 (2.6) |
| CRP increased | 5 (13.2) | 0 (0.0) | 0 (0.0) |
| Weight decreased | 5 (13.2) | 0 (0.0) | 0 (0.0) |
| Vasculitis | 5 (13.2) | 0 (0.0) | 0 (0.0) |
| Hypokalemia | 4 (10.5) | 0 (0.0) | 1 (2.6) |
| Stomatitis | 4 (10.5) | 1 (2.6) | 0 (0.0) |
| Blood creatinine increased | 4 (10.5) | 0 (0.0) | 0 (0.0) |
| LDH increased | 4 (10.5) | 0 (0.0) | 0 (0.0) |
| Taste disorder | 4 (10.5) | 0 (0.0) | 0 (0.0) |
| Pruritus | 4 (10.5) | 0 (0.0) | 0 (0.0) |
Terms: expressed according to Medical Dictionary for Regulatory Activities Japanese version 22.1
Grades: assessed according to CTCAE version 4.0-JCOG
TEAEs treatment-emergent adverse events, n number of patients, CTCAE common terminology criteria for adverse events, JCOG Japan Clinical Oncology Group, Ig immunoglobulin, ALT alanine aminotransferase, AST aspartate aminotransferase, γ-GTP gamma-glutamyl transpeptidase, CRP C-reactive protein, LDH lactate dehydrogenase