AEs during exposure to leniolisib
| . | DFT . | OLE . | ||||
|---|---|---|---|---|---|---|
| 70-mg∗ . | Year 1 . | Year 2 . | Year 3 . | Year 4 . | Year 5 . | |
| Overall AE incidence,†,‡,§ | ||||||
| All, nE, nS (%) | 11, 4 (36) | 36, 6 (100) | 14, 5 (83) | 10, 4 (36)ǁ | 14, 5 (83)ǁ | 9, 3 (50)ǁ |
| Grade 1, nE, nS (%) | 9, 4 (67) | 32, 6 (100) | 13, 5 (83) | 7, 4 (36) | 6, 3 (50) | 8, 2 (33) |
| Grade 2, nE, nS (%) | 2, 1 (17) | 4, 2 (33) | 1, 1 (17) | 2, 2 (33) | 5, 2 (33) | 0, 0 (0) |
| Grade 3, nE, nS (%) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 2, 1 (17) | 0, 0 (0) |
| Grade 4, nE, nS (%) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) |
| Grade 5, nE, nS (%) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) |
| Study drug related, nE, nS (%) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) |
| Serious, nE, nS (%) | 0, 0, (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 1, 1 (17) | 0, 0 (0) |
| . | DFT . | OLE . | ||||
|---|---|---|---|---|---|---|
| 70-mg∗ . | Year 1 . | Year 2 . | Year 3 . | Year 4 . | Year 5 . | |
| Overall AE incidence,†,‡,§ | ||||||
| All, nE, nS (%) | 11, 4 (36) | 36, 6 (100) | 14, 5 (83) | 10, 4 (36)ǁ | 14, 5 (83)ǁ | 9, 3 (50)ǁ |
| Grade 1, nE, nS (%) | 9, 4 (67) | 32, 6 (100) | 13, 5 (83) | 7, 4 (36) | 6, 3 (50) | 8, 2 (33) |
| Grade 2, nE, nS (%) | 2, 1 (17) | 4, 2 (33) | 1, 1 (17) | 2, 2 (33) | 5, 2 (33) | 0, 0 (0) |
| Grade 3, nE, nS (%) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 2, 1 (17) | 0, 0 (0) |
| Grade 4, nE, nS (%) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) |
| Grade 5, nE, nS (%) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) |
| Study drug related, nE, nS (%) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) |
| Serious, nE, nS (%) | 0, 0, (0) | 0, 0 (0) | 0, 0 (0) | 0, 0 (0) | 1, 1 (17) | 0, 0 (0) |
AEs were reported through clinical assessments, nondirective interviewing of each patient, or as volunteered by the patient. Detected AEs were followed-up until resolution.
nE, number of events in the category; nS, number of patients with at least 1 AE in the category.
Only AEs from 70-mg treatment period are included.
% is based on the number of patients.
Common Toxicity Criteria were used to determine AE grade.
AEs captured in the DFT and OLE were collected from AE files that had a cutoff date of 13 December 2021.
Includes negative COVID-19 test result(s) that did not have a grade.