TEAEs by maximum severity occurring in at least 25% of patients in any treatment arm
| Preferred term . | BV+DTIC (n = 22) . | BV+bendamustine (n = 20) . | ||||||
|---|---|---|---|---|---|---|---|---|
| G1/2 . | G3 . | G4 . | Total . | G1/2 . | G3 . | G4 . | Total . | |
| Diarrhea | 6 (27) | — | — | 6 (27) | 17 (85) | — | — | 17 (85) |
| Nausea | 9 (41) | — | — | 9 (41) | 13 (65) | — | — | 13 (65) |
| Fatigue | 9 (41) | — | — | 9 (41) | 7 (35) | 3 (15) | — | 10 (50) |
| Decreased appetite | 5 (23) | — | — | 5 (23) | 8 (40) | 1 (5) | — | 9 (45) |
| PSN | 11 (50) | 6 (27) | — | 17 (77) | 5 (25) | 3 (15) | — | 8 (40) |
| Pyrexia | 2 (9) | — | — | 2 (9) | 8 (40) | — | — | 8 (40) |
| Constipation | 10 (45) | — | — | 10 (45) | 7 (35) | — | — | 7 (35) |
| Dehydration | 1 (5) | — | — | 1 (5) | 6 (30) | 1 (5) | — | 7 (35) |
| Urinary tract infection | 1 (5) | 1 (5) | — | 2 (9) | 4 (20) | 2 (10) | 1 (5) | 7 (35) |
| Cough | 4 (18) | — | — | 4 (18) | 5 (25) | 1 (5) | — | 6 (30) |
| Edema peripheral | 7 (32) | — | — | 7 (32) | 6 (30) | — | — | 6 (30) |
| Hypokalemia | — | — | — | — | 4 (20) | 1 (5) | 1 (5) | 6 (30) |
| Hypotension | — | 1 (5) | — | 1 (5) | 4 (20) | 2 (10) | — | 6 (30) |
| Abdominal pain | 3 (14) | — | — | 3 (14) | 5 (25) | — | — | 5 (25) |
| Alopecia | 4 (18) | — | — | 4 (18) | 5 (25) | — | — | 5 (25) |
| Dyspnea | 5 (23) | — | — | 5 (23) | 4 (20) | 1 (5) | — | 5 (25) |
| Fall | 5 (23) | — | — | 5 (23) | 5 (25) | — | — | 5 (25) |
| Neutropenia | 1 (5) | 1 (5) | 1 (5) | 3 (14) | 3 (15) | 1 (5) | 1 (5) | 5 (25) |
| Weight decreased | 4 (18) | 1 (5) | — | 5 (23) | 4 (20) | 1 (5) | — | 5 (25) |
| Preferred term . | BV+DTIC (n = 22) . | BV+bendamustine (n = 20) . | ||||||
|---|---|---|---|---|---|---|---|---|
| G1/2 . | G3 . | G4 . | Total . | G1/2 . | G3 . | G4 . | Total . | |
| Diarrhea | 6 (27) | — | — | 6 (27) | 17 (85) | — | — | 17 (85) |
| Nausea | 9 (41) | — | — | 9 (41) | 13 (65) | — | — | 13 (65) |
| Fatigue | 9 (41) | — | — | 9 (41) | 7 (35) | 3 (15) | — | 10 (50) |
| Decreased appetite | 5 (23) | — | — | 5 (23) | 8 (40) | 1 (5) | — | 9 (45) |
| PSN | 11 (50) | 6 (27) | — | 17 (77) | 5 (25) | 3 (15) | — | 8 (40) |
| Pyrexia | 2 (9) | — | — | 2 (9) | 8 (40) | — | — | 8 (40) |
| Constipation | 10 (45) | — | — | 10 (45) | 7 (35) | — | — | 7 (35) |
| Dehydration | 1 (5) | — | — | 1 (5) | 6 (30) | 1 (5) | — | 7 (35) |
| Urinary tract infection | 1 (5) | 1 (5) | — | 2 (9) | 4 (20) | 2 (10) | 1 (5) | 7 (35) |
| Cough | 4 (18) | — | — | 4 (18) | 5 (25) | 1 (5) | — | 6 (30) |
| Edema peripheral | 7 (32) | — | — | 7 (32) | 6 (30) | — | — | 6 (30) |
| Hypokalemia | — | — | — | — | 4 (20) | 1 (5) | 1 (5) | 6 (30) |
| Hypotension | — | 1 (5) | — | 1 (5) | 4 (20) | 2 (10) | — | 6 (30) |
| Abdominal pain | 3 (14) | — | — | 3 (14) | 5 (25) | — | — | 5 (25) |
| Alopecia | 4 (18) | — | — | 4 (18) | 5 (25) | — | — | 5 (25) |
| Dyspnea | 5 (23) | — | — | 5 (23) | 4 (20) | 1 (5) | — | 5 (25) |
| Fall | 5 (23) | — | — | 5 (23) | 5 (25) | — | — | 5 (25) |
| Neutropenia | 1 (5) | 1 (5) | 1 (5) | 3 (14) | 3 (15) | 1 (5) | 1 (5) | 5 (25) |
| Weight decreased | 4 (18) | 1 (5) | — | 5 (23) | 4 (20) | 1 (5) | — | 5 (25) |
Data are presented as n (%) of patients. TEAEs are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product and in descending order of patient incidence in the BV plus bendamustine arm.
G, grade.