Table 2.
Grade 3 or higher adverse events and serious adverse events in patients receiving G-B in cohort 1 of the GREEN study (safety population)
| n (%) | All patients (N = 158) | Fit patientsa (n = 70) | Unfit patientsb (n = 88) |
|---|---|---|---|
| Grade ≥3 AEs (reported by ≥2% patients in overall population) by preferred term | |||
| Any | 130 (82.3) | 52 (74.3) | 78 (88.6) |
| Neutropenia | 78 (49.4) | 34 (48.6) | 44 (50.0) |
| Thrombocytopenia | 19 (12.0) | 8 (11.4) | 11 (12.5) |
| Febrile neutropenia | 17 (10.8) | 8 (11.4) | 9 (10.2) |
| Lymphopenia | 14 (8.9) | 6 (8.6) | 8 (9.1) |
| Anemia | 13 (8.2) | 3 (4.3) | 10 (11.4) |
| Leukopenia | 13 (8.2) | 6 (8.6) | 7 (8.0) |
| Tumor lysis syndrome | 13 (8.2) | 2 (2.9) | 11 (12.5) |
| Pneumonia | 12 (7.6) | 5 (7.1) | 7 (8.0) |
| Hypertension | 11 (7.0) | 5 (7.1) | 6 (6.8) |
| Hyperglycemia | 6 (3.8) | 4 (5.7) | 2 (2.3) |
| Squamous cell carcinoma | 5 (3.2) | 1 (1.4) | 4 (4.5) |
| Diarrhea | 4 (2.5) | 0 | 4 (4.5) |
| Hyperuricemia | 4 (2.5) | 4 (5.7) | 0 |
| Serious AEs (reported by ≥2% patients in overall population) by preferred term | |||
| Any | 96 (60.8) | 37 (52.9) | 59 (67.0) |
| Neutropenia | 20 (12.7) | 9 (12.9) | 11 (12.5) |
| Febrile neutropenia | 15 (9.5) | 6 (8.6) | 9 (10.2) |
| Pneumonia | 12 (7.6) | 5 (7.1) | 7 (8.0) |
| Pyrexia | 11 (7.0) | 4 (5.7) | 7 (8.0) |
| Tumor lysis syndrome | 6 (3.8) | 0 | 6 (6.8) |
| Squamous cell carcinoma | 4 (2.5) | 1 (1.4) | 3 (3.4) |
| Thrombocytopenia | 4 (2.5) | 1 (1.4) | 3 (3.4) |
| Grade ≥3 AESI/AEPIc | |||
| Neutropenia | 84 (53.2) | 37 (52.9) | 47 (53.4) |
| Infections | 32 (20.3) | 11 (15.7) | 21 (23.9) |
| IRRs | 27 (17.1) | 9 (12.9) | 18 (20.5) |
| Thrombocytopenia | 19 (12.0) | 8 (11.4) | 11 (12.5) |
| Second malignancies | 13 (8.2) | 4 (5.7) | 9 (10.2) |
| Tumor lysis syndrome | 13 (8.2) | 2 (2.9) | 11 (12.5) |
AE adverse event, AEPI adverse events of particular interest, AESI adverse events of special interest, CIRS Cumulative Illness Rating Scale, CrCl creatinine clearance, G-B obinutuzumab plus bendamustine, IRR infusion-related reaction, MedDRA Medical Dictionary for Regulatory Activities
a CIRS ≤6 and CrCl ≥70 ml/min
b CIRS >6 and/or CrCl <70 ml/min
c IRRs were defined as any AE occurring during or within 24 h of obinutuzumab infusion and considered related to obinutuzumab; infection selection was via the MedDRA system order class ‘Infections and Infestations’; second malignancy selection was via the MedDRA system organ class ‘Neoplasms Benign, Malignant, and Unspecified’ starting 6 months after the first study drug intake; neutropenia and thrombocytopenia selection was via their MedDRA basket dataset subgroups; and tumor lysis syndrome was defined by its preferred term