TABLE 3.
Common adverse events
| Adverse events — n (%) | Cohort A Treatment‐naïve N = 18 | Cohort B Relapsed/refractory N = 9 | Total N = 27 | |
|---|---|---|---|---|
| All | 18 (100) | 9 (100) | 27 (100) | |
| Grade ≥ 3 | 4 (22.2) | 4 (44.4) | 8 (29.6) | |
| Rash | 11 (61.1) | 1 (11.1) | 12 (44.4) | |
| Neutropenia | 2 (11.1) | 5 (55.6) | 7 (25.9) | |
| Grade ≥ 3 | 0 | 3 (33.3) | 3 (11.1) | |
| Leukopenia | 2 (11.1) | 4 (44.4) | 6 (22.2) | |
| Grade ≥ 3 | 0 | 2 (22.2) | 2 (7.4) | |
| Stomatitis | 3 (16.7) | 1 (11.1) | 4 (14.8) | |
| Thrombocytopenia | 3 (16.7) | 0 | 3 (11.1) | |
| Rash maculopapular | 3 (16.7) | 0 | 3 (11.1) | |
| Nausea | 2 (11.1) | 1 (11.1) | 3 (11.1) | |
| Nasopharyngitis | 1 (5.6) | 2 (22.2) | 3 (11.1) | |
| Lymphopenia | 1 (5.6) | 2 (22.2) | 3 (11.1) | |
| Grade ≥ 3 | 1 (5.6) | 2 (22.2) | 3 (11.1) | |
| Diarrhea | 2 (11.1) | 0 | 2 (7.4) | |
| Urinary tract infection | 2 (11.1) | 0 | 2 (7.4) | |
| Pruritus | 2 (11.1) | 0 | 2 (7.4) | |
| Cataract | 1 (5.6) | 1 (11.1) | 2 (7.4) | |
| Constipation | 1 (5.6) | 1 (11.1) | 2 (7.4) | |
| Pyrexia | 1 (5.6) | 1 (11.1) | 2 (7.4) | |
| Weight decreased | 1 (5.6) | 1 (11.1) | 2 (7.4) | |
| Insomnia | 1 (5.6) | 1 (11.1) | 2 (7.4) | |
| Epistaxis | 1 (5.6) | 1 (11.1) | 2 (7.4) | |
| Bronchitis | 0 | 2 (22.2) | 2 (7.4) | |
| Rhegmatogenous retinal | Grade ≥ 3 | 1 (5.6) | 0 | 1 (3.7) |
| Atypical mycobacterial | Grade ≥ 3 | 1 (5.6) | 0 | 1 (3.7) |
| Erythema multiforme | Grade ≥ 3 | 1 (5.6) | 0 | 1 (3.7) |
| Rash erythematous | Grade ≥ 3 | 1 (5.6) | 0 | 1 (3.7) |
| Type 2 diabetes mellitus | Grade ≥ 3 | 0 | 1 (11.1) | 1 (3.7) |
Adverse events observed in more than 2 patients and those with grade ≥ 3 were listed.