Summary of most common TEAEs (safety analysis set)
| . | Copanlisib + R-B∗ (n = 263) . | Placebo + R-B (n = 257) . | ||||
|---|---|---|---|---|---|---|
| All grade . | Grade 3 . | Grade 4 . | All grade . | Grade 3 . | Grade 4 . | |
| Any TEAE, n (%) | 263 (100) | 83 (31.6) | 162 (61.6) | 250 (97.3) | 89 (34.6) | 114 (44.4) |
| Most common TEAEs occurring in ≥20% of patients in either treatment arm, n (%) | ||||||
| Hyperglycemia | 152 (57.8) | 99 (37.6) | 13 (4.9) | 53 (20.6) | 13 (5.1) | 0 |
| Hypertension | 116 (44.1) | 90 (34.2) | 0 | 42 (16.3) | 21 (8.2) | 1 (0.4) |
| Nausea | 112 (42.6) | 2 (0.8) | 0 | 92 (35.8) | 3 (1.2) | 0 |
| Decreased neutrophil count | 110 (41.8) | 39 (14.8) | 60 (22.8) | 83 (32.3) | 34 (13.2) | 32 (12.5) |
| Pyrexia | 103 (39.2) | 6 (2.3) | 0 | 36 (14.0) | 1 (0.4) | 0 |
| Diarrhea | 89 (33.8) | 10 (3.8) | 1 (0.4) | 38 (14.8) | 3 (1.2) | 0 |
| Neutropenia | 87 (33.1) | 36 (13.7) | 43 (16.3) | 88 (34.2) | 36 (14.0) | 39 (15.2) |
| Anemia | 86 (32.7) | 18 (6.8) | 0 | 64 (24.9) | 10 (3.9) | 1 (0.4) |
| Decreased white blood cell count | 79 (30.0) | 44 (16.7) | 16 (6.1) | 65 (25.3) | 37 (14.4) | 9 (3.5) |
| Decreased lymphocyte count | 73 (27.8) | 11 (4.2) | 61 (23.2) | 50 (19.5) | 12 (4.7) | 38 (14.8) |
| Decreased platelet count | 72 (27.4) | 13 (4.9) | 6 (2.3) | 52 (20.2) | 9 (3.5) | 1 (0.4) |
| Decreased weight | 64 (24.3) | 4 (1.5) | 0 | 21 (8.2) | 0 | 0 |
| Vomiting | 59 (22.4) | 1 (0.4) | 0 | 31 (12.1) | 0 | 0 |
| Rash | 59 (22.4) | 3 (1.1) | 0 | 26 (10.1) | 2 (0.8) | 0 |
| Pneumonia | 56 (21.3) | 26 (9.9) | 2 (0.8) | 6 (2.3) | 3 (1.2) | 0 |
| Most common serious TEAEs occurring in ≥2% of patients in either treatment arm, n (%) | ||||||
| Pneumonia | 34 (12.9) | 21 (8.0) | 2 (0.8) | 3 (1.2) | 2 (0.8) | 0 |
| Pyrexia | 22 (8.4) | 5 (1.9) | 0 | 4 (1.6) | 1 (0.4) | 0 |
| Febrile neutropenia | 18 (6.8) | 11 (4.2) | 5 (1.9) | 8 (3.1) | 5 (1.9) | 2 (0.8) |
| Cytomegalovirus infection | 12 (4.6) | 8 (3.0) | 1 (0.4) | 2 (0.8) | 2 (0.8) | 0 |
| Hyperglycemia | 10 (3.8) | 7 (2.7) | 3 (1.1) | 1 (0.4) | 1 (0.4) | 0 |
| Decreased neutrophil count | 7 (2.7) | 1 (0.4) | 5 (1.9) | 3 (1.2) | 1 (0.4) | 2 (0.8) |
| Interstitial lung disease | 7 (2.7) | 4 (1.5) | 0 | 0 | 0 | 0 |
| Diarrhea | 6 (2.3) | 5 (1.9) | 1 (0.4) | 0 | 0 | 0 |
| TEAEs leading to discontinuation of copanlisib/placebo, n (%) | 57 (21.7)† | 33 (12.5) | 11 (4.2) | 15 (5.8) | 10 (3.9) | 4 (1.6) |
| TEAEs of interest, n (%) | ||||||
| Pneumonitis | 8 (3.0) | 1 (0.4) | 1 (0.4) | 2 (0.8) | 0 | 0 |
| Colitis | 3 (1.1) | 1 (0.4) | 0 | 2 (0.8) | 0 | 0 |
| . | Copanlisib + R-B∗ (n = 263) . | Placebo + R-B (n = 257) . | ||||
|---|---|---|---|---|---|---|
| All grade . | Grade 3 . | Grade 4 . | All grade . | Grade 3 . | Grade 4 . | |
| Any TEAE, n (%) | 263 (100) | 83 (31.6) | 162 (61.6) | 250 (97.3) | 89 (34.6) | 114 (44.4) |
| Most common TEAEs occurring in ≥20% of patients in either treatment arm, n (%) | ||||||
| Hyperglycemia | 152 (57.8) | 99 (37.6) | 13 (4.9) | 53 (20.6) | 13 (5.1) | 0 |
| Hypertension | 116 (44.1) | 90 (34.2) | 0 | 42 (16.3) | 21 (8.2) | 1 (0.4) |
| Nausea | 112 (42.6) | 2 (0.8) | 0 | 92 (35.8) | 3 (1.2) | 0 |
| Decreased neutrophil count | 110 (41.8) | 39 (14.8) | 60 (22.8) | 83 (32.3) | 34 (13.2) | 32 (12.5) |
| Pyrexia | 103 (39.2) | 6 (2.3) | 0 | 36 (14.0) | 1 (0.4) | 0 |
| Diarrhea | 89 (33.8) | 10 (3.8) | 1 (0.4) | 38 (14.8) | 3 (1.2) | 0 |
| Neutropenia | 87 (33.1) | 36 (13.7) | 43 (16.3) | 88 (34.2) | 36 (14.0) | 39 (15.2) |
| Anemia | 86 (32.7) | 18 (6.8) | 0 | 64 (24.9) | 10 (3.9) | 1 (0.4) |
| Decreased white blood cell count | 79 (30.0) | 44 (16.7) | 16 (6.1) | 65 (25.3) | 37 (14.4) | 9 (3.5) |
| Decreased lymphocyte count | 73 (27.8) | 11 (4.2) | 61 (23.2) | 50 (19.5) | 12 (4.7) | 38 (14.8) |
| Decreased platelet count | 72 (27.4) | 13 (4.9) | 6 (2.3) | 52 (20.2) | 9 (3.5) | 1 (0.4) |
| Decreased weight | 64 (24.3) | 4 (1.5) | 0 | 21 (8.2) | 0 | 0 |
| Vomiting | 59 (22.4) | 1 (0.4) | 0 | 31 (12.1) | 0 | 0 |
| Rash | 59 (22.4) | 3 (1.1) | 0 | 26 (10.1) | 2 (0.8) | 0 |
| Pneumonia | 56 (21.3) | 26 (9.9) | 2 (0.8) | 6 (2.3) | 3 (1.2) | 0 |
| Most common serious TEAEs occurring in ≥2% of patients in either treatment arm, n (%) | ||||||
| Pneumonia | 34 (12.9) | 21 (8.0) | 2 (0.8) | 3 (1.2) | 2 (0.8) | 0 |
| Pyrexia | 22 (8.4) | 5 (1.9) | 0 | 4 (1.6) | 1 (0.4) | 0 |
| Febrile neutropenia | 18 (6.8) | 11 (4.2) | 5 (1.9) | 8 (3.1) | 5 (1.9) | 2 (0.8) |
| Cytomegalovirus infection | 12 (4.6) | 8 (3.0) | 1 (0.4) | 2 (0.8) | 2 (0.8) | 0 |
| Hyperglycemia | 10 (3.8) | 7 (2.7) | 3 (1.1) | 1 (0.4) | 1 (0.4) | 0 |
| Decreased neutrophil count | 7 (2.7) | 1 (0.4) | 5 (1.9) | 3 (1.2) | 1 (0.4) | 2 (0.8) |
| Interstitial lung disease | 7 (2.7) | 4 (1.5) | 0 | 0 | 0 | 0 |
| Diarrhea | 6 (2.3) | 5 (1.9) | 1 (0.4) | 0 | 0 | 0 |
| TEAEs leading to discontinuation of copanlisib/placebo, n (%) | 57 (21.7)† | 33 (12.5) | 11 (4.2) | 15 (5.8) | 10 (3.9) | 4 (1.6) |
| TEAEs of interest, n (%) | ||||||
| Pneumonitis | 8 (3.0) | 1 (0.4) | 1 (0.4) | 2 (0.8) | 0 | 0 |
| Colitis | 3 (1.1) | 1 (0.4) | 0 | 2 (0.8) | 0 | 0 |
Medical Dictionary for Regulatory Activities version 26.0. Common Terminology Criteria for Adverse Events version 4.03.
Two patients were randomized to placebo plus R-B but received ≥1 dose of copanlisib by mistake and are thus included in the copanlisib plus R-B arm.
Includes 5 grade 5 TEAEs leading to discontinuation.