Table 2.
Treatment-emergent AEs occurring in more than or equal to 15% of patients
| N = 21 |
||||
|---|---|---|---|---|
| Any grade | Grade 1-2 | Grade 3-4 | Grade 5 | |
| Patients with an event, n (%)∗ | 21 (100) | 4 (19.0) | 13 (61.9) | 4 (19.0) |
| Diarrhea | 15 (71.4) | 14 (66.7) | 1 (4.8) | 0 |
| Headache | 11 (52.4) | 11 (52.4) | 0 | 0 |
| Fatigue | 10 (47.6) | 10 (47.6) | 0 | 0 |
| Neutropenia | 8 (38.1) | 1 (4.8) | 7 (33.3) | 0 |
| COVID-19 | 7 (33.3) | 1 (4.8) | 2 (9.5) | 4 (19.0)† |
| Dizziness | 7 (33.3) | 7 (33.3) | 0 | 0 |
| Cough | 6 (28.6) | 6 (28.6) | 0 | 0 |
| Paresthesia | 6 (28.6) | 6 (28.6) | 0 | 0 |
| Dyspnea | 5 (23.8) | 4 (19.0) | 1 (4.8) | 0 |
| Hypoesthesia | 5 (23.8) | 5 (23.8) | 0 | 0 |
| Myalgia | 5 (23.8) | 5 (23.8) | 0 | 0 |
| Memory impairment | 4 (19.0) | 4 (19.0) | 0 | 0 |
| Peripheral edema | 4 (19.0) | 3 (14.3) | 1 (4.8) | 0 |
| Pruritus | 4 (19.0) | 4 (19.0) | 0 | 0 |
| Upper respiratory tract infection | 4 (19.0) | 4 (19.0) | 0 | 0 |
| Blurred vision | 4 (19.0) | 4 (19.0) | 0 | 0 |
Regardless of causality assessment.
∗
A patient with multiple severity grades for a given AE is counted only once under the maximum severity.
†
A fifth patient died from COVID-19 infection outside the treatment-emergent period (30 days after discontinuation of all study drugs).