Table II.
Treatment-related, treatment-emergent AEs occurring in >10% of patients in either R-InO or IC arm.
| R-InO (n=164) | IC (n=167) | |||
|---|---|---|---|---|
| Any grade | Grade ≥3 | Any grade | Grade 3/4 | |
| Any AE, n (%) | 148 (90) | 102 (62) | 146 (87) | 107 (64) |
| Thrombocytopenia | 99 (60) | 78 (48) | 59 (35) | 26 (16) |
| Neutropenia | 57 (35) | 40 (24) | 79 (47) | 67 (40) |
| Fatigue | 38 (23) | 5 (3) | 31 (19) | 1 (1) |
| Nausea | 39 (24) | 0 | 25 (27) | 0 |
| AST increased | 43 (26) | 7 (4) | 15 (9) | 4 (2) |
| Pyrexia | 16 (10) | 1 (1) | 20 (12) | 2 (1) |
| Constipation | 18 (11) | 0 | 14 (8) | 0 |
| GGT increased | 31 (19) | 7 (4) | 8 (5) | 0 |
| Leucopenia | 35 (21) | 13 (8) | 52 (31) | 39 (23) |
| ALT increased | 28 (17) | 7 (4) | 13 (8) | 2 (1) |
| Decreased appetite | 20 (12) | 2 (1) | 24 (14) | 0 |
| Lymphopenia | 26 (16) | 15 (9) | 38 (23) | 37 (22) |
| Anaemia | 17 (10) | 7 (4) | 39 (23) | 12 (7) |
| Blood ALP increased | 22 (13) | 1 (1) | 9 (5) | 1 (1) |
| Cough | 4 (2) | 0 | 5 (3) | 1 (1) |
| Vomiting | 14 (9) | 0 | 22 (13) | 0 |
| Diarrhoea | 10 (6) | 0 | 17 (10) | 1 (1) |
AE=adverse event; ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; GGT=gamma-glutamyl transferase; IC=investigator’s choice (rituximab plus bendamustine or rituximab plus gemcitabine); R-InO=inotuzumab plus rituximab.