Table 3.
Overview of TEAEs and incidence of TEAEs and drug-related TEAEs occurring in ≥10% of the total population (overall cohort).
| n (%) | Grade 1 or 2 | Grade 3 or 4 | Grade 5 | Total N = 67 |
|---|---|---|---|---|
| Any TEAEa | 7 (10.4) | 44 (65.7) | 14 (20.9) | 65 (97.0) |
| SAEs | 2 (3.0) | 28 (41.8) | 14 (20.9) | 44 (65.7) |
| Patients with TEAEs leading to dose reduction | 2 (3.0) | 7 (10.4) | 0 | 9 (13.4) |
| Patients with TEAEs leading to dose interruption/delay | 11 (16.4) | 23 (34.3) | 0 | 34 (50.7) |
| Patients with TEAEs leading to permanent discontinuation | 4 (6.0) | 13 (19.4) | 0 | 17 (25.4) |
| Incidence of TEAEs occurring in >10% of the total population | ||||
| Hypertension | 5 (7.5) | 22 (32.8) | 0 | 27 (40.3) |
| Diarrhea | 24 (35.8) | 1 (1.5) | 0 | 25 (37.3) |
| Hyperglycemia | 1 (1.5) | 21 (31.3) | 0 | 22 (32.8) |
| Nausea | 20 (29.9) | 1 (1.5) | 0 | 21 (31.3) |
| Fatigue | 18 (26.9) | 0 | 1 (1.5)b | 19 (28.4) |
| Pyrexia | 13 (19.4) | 1 (1.5) | 0 | 14 (20.9) |
| Cough | 11 (16.4) | 1 (1.5) | 0 | 12 (17.9) |
| Vomiting | 11 (16.4) | 1 (1.5) | 0 | 12 (17.9) |
| Constipation | 11 (16.4) | 0 | 0 | 11 (16.4) |
| Decreased appetite | 10 (14.9) | 0 | 0 | 10 (14.9) |
| Deterioration in general physical health | 0 | 1 (1.5) | 8 (11.9) | 9 (13.4) |
| Headache | 9 (13.4) | 0 | 0 | 9 (13.4) |
| Neutropenia | 1 (1.5) | 8 (11.9) | 0 | 9 (13.4) |
| Rash | 8 (11.9) | 1 (1.5) | 0 | 9 (13.4) |
| Hypokalemia | 4 (6.0) | 4 (6.0) | 0 | 8 (11.9) |
| Mouth ulceration | 7 (10.4) | 1 (1.5) | 0 | 8 (11.9) |
| Dyspnea | 4 (6.0) | 3 (4.5) | 0 | 7 (10.4) |
| Peripheral edema | 7 (10.4) | 0 | 0 | 7 (10.4) |
| Incidence of drug-related TEAEs occurring in >10% of the total population | ||||
| Hypertension | 4 (6.0) | 19 (28.4) | 0 | 23 (34.3) |
| Hyperglycemia | 1 (1.5) | 20 (29.9) | 0 | 21 (31.3) |
| Fatigue | 12 (17.9) | 0 | 0 | 12 (17.9) |
| Nausea | 12 (17.9) | 0 | 0 | 12 (17.9) |
| Diarrhea | 10 (14.9) | 1 (1.5) | 0 | 11 (16.4) |
| Vomiting | 7 (10.4) | 1 (1.5) | 0 | 8 (11.9) |
| Mouth ulceration | 6 (9.0) | 1 (1.5) | 0 | 7 (10.4) |
| Neutropenia | 1 (1.5) | 6 (9.0) | 0 | 7 (10.4) |
SAE serious adverse event, TEAE treatment-emergent adverse event.
aSpecified event starting or worsening between start of treatment and 30 days after the end of treatment.
bThis patient received treatment with copanlisib for 14 days and was withdrawn from the study due to disease progression. The patient experienced increasing fatigue that was considered an SAE due to hospitalization occurring 15 days after the last dose of copanlisib, with a reported grade 5 (fatal) outcome occurring 2 days later, considered as a symptom of disease progression. The event was considered unrelated to treatment with copanlisib or protocol-required procedures, with the primary cause of death reported as underlying disease.