TABLE 2.
Treatment‐emergent adverse events by treatment arm (safety population) a
| Arm A | Arm B | Arm C | Arm D | |||||
|---|---|---|---|---|---|---|---|---|
| Avadomide + CC‐223 ± R (n = 31) | Avadomide + CC‐292 ± R (n = 27) | CC‐292 + CC‐223 (n = 14) | Avadomide + R (n = 30) | |||||
| Any grade | Grade 3/4 | Any grade | Grade 3/4 | Any grade | Grade 3/4 | Any grade | Grade 3/4 | |
| Any TEAE, n (%) | 31 (100) | 27 (87.1) | 27 (100) | 25 (92.6) | 14 (100) | 14 (100) | 30 (100) | 22 (73.3) |
| Hematologic | ||||||||
| Neutropenia | 15 (48.4) | 14 (45.2) | 12 (44.4) | 12 (44.4) | 3 (21.4) | 2 (14.3) | 15 (50.0) | 11 (36.7) |
| Anemia | 9 (29.0) | 4 (12.9) | 6 (22.2) | 5 (18.5) | 2 (14.3) | 2 (14.3) | 8 (26.7) | – |
| Thrombocytopenia | 7 (22.6) | 5 (16.1) | 11 (40.7) | 7 (25.9) | 5 (35.7) | 4 (28.6) | 5 (16.7) | 4 (13.3) |
| Febrile neutropenia | 3 (9.7) | 3 (9.7) | 5 (18.5) | 5 (18.5) | – | – | 2 (6.7) | 2 (6.7) |
| Gastrointestinal | ||||||||
| Diarrhea | 21 (67.7) | 6 (19.4) | 12 (44.4) | – | 9 (64.3) | 2 (14.3) | 3 (10.0) | – |
| Abdominal pain | 7 (22.6) | – | 8 (29.6) | – | – | – | – | – |
| Nausea | 6 (19.4) | – | 8 (29.6) | – | 3 (21.4) | – | 5 (16.7) | – |
| Vomiting | 6 (19.4) | – | 4 (14.8) | – | 3 (21.4) | – | 3 (10.0) | – |
| Constipation | 4 (12.9) | – | 3 (11.1) | – | – | – | 6 (20.0) | – |
| Dyspepsia | – | – | 4 (14.8) | – | 3 (21.4) | – | – | – |
| Other | ||||||||
| Hypokalemia | 12 (38.7) | 3 (9.7) | 3 (11.1) | – | 3 (21.4) | – | – | – |
| Pyrexia | 12 (38.7) | – | 10 (37.0) | – | 4 (28.6) | – | 10 (33.3) | – |
| Fatigue | 12 (38.7) | 2 (6.5) | 8 (29.6) | 2 (7.4) | 2 (14.3) | – | 3 (10.0) | – |
| Cough | 11 (35.5) | – | 4 (14.8) | 3 (21.4) | – | 8 (26.7) | – | |
| Dyspnea | 11 (35.5) | – | 7 (25.9) | 2 (7.4) | – | – | 8 (26.7) | – |
| Rash | 11 (35.5) | – | 3 (11.1) | – | 2 (14.3) | – | 5 (16.7) | – |
| Decreased appetite | 9 (29.0) | – | – | – | – | – | 7 (23.3) | – |
| Hyperglycemia | 9 (29.0) | 2 (6.5) | – | – | 2 (14.3) | – | – | – |
| Overdose | 7 (22.6) | – | 3 (11.1) | – | 2 (14.3) | – | – | – |
| Blood creatinine increased | 6 (19.4) | – | 3 (11.1) | – | 2 (14.3) | – | – | – |
| Proteinuria | 6 (19.4) | – | – | – | – | – | – | – |
| Pruritus | 5 (16.1) | – | 3 (11.1) | – | – | – | 8 (26.7) | – |
| Asthenia | 5 (16.1) | 2 (6.5) | – | – | 4 (28.6) | 3 (21.4) | 5 (16.7) | 2 (6.7) |
| Urinary tract infection | 5 (16.1) | – | 4 (14.8) | – | – | – | 4 (13.3) | – |
| Dizziness | 5 (16.1) | – | – | – | – | – | 3 (10.0) | – |
| Edema peripheral | 4 (12.9) | – | 6 (22.2) | – | 4 (28.6) | – | 4 (13.3) | – |
| AST increased | 4 (12.9) | – | 5 (18.5) | – | – | – | 3 (10.0) | – |
| Hypotension | 4 (12.9) | – | – | – | 5 (35.7) | 4 (28.6) | 3 (10.0) | 2 (6.7) |
| General health deterioration b | – | – | 8 (29.6) | 5 (18.5) | 2 (14.3) | 2 (14.3) | 4 (13.3) | – |
| Noncardiac chest pain | – | – | 4 (14.8) | 3 (11.1) | – | – | – | – |
| Hyperbilirubinemia | – | – | 4 (14.8) | – | – | – | – | – |
| Pneumonia | – | – | 4 (14.8) | – | – | – | – | 2 (6.7) |
| Headache | – | – | 4 (14.8) | – | – | – | – | – |
Abbreviations: AST, aspartate aminotransferase; R, rituximab; TEAE, treatment‐emergent adverse event.
a
Events of any grade occurring in ≥15% of patients and grade 3/4 events occurring in ≥5% of patients by treatment arm are reported. Dashes indicate an incidence not meeting these cutoffs.
b
General health deterioration included clinical disease progression or worsening health status; patients did not meet the criteria for radiographic disease progression.