TABLE 3.
Adverse events |
Cohort A Treatment‐naïve (N = 18) |
Cohort B Relapsed/refractory (N = 9) |
All (N = 27) | |||
---|---|---|---|---|---|---|
Any grade | Grade 3–4 | Any grade | Grade 3–4 | Any grade | Grade 3–4 | |
Any | 18 (100) | 7 (39) | 9 (100) | 5 (56) | 27 (100) | 12 (44) |
Rash | 11 (61) | 0 | 1 (11) | 0 | 12 (44) | 0 |
Neutropenia | 3 (17) | 2 (11) | 5 (56) | 4 (44) | 8 (30) | 6 (22) |
Nasopharyngitis | 3 (17) | 0 | 4 (44) | 0 | 7 (26) | 0 |
Leukopenia | 2 (11) | 0 | 4 (44) | 3 (33) | 6 (22) | 3 (11) |
Lymphopenia | 2 (11) | 2 (11) | 3 (33) | 3 (33) | 5 (19) | 5 (19) |
Stomatitis | 3 (17) | 0 | 2 (22) | 0 | 5 (19) | 0 |
Constipation | 3 (17) | 0 | 1 (11) | 0 | 4 (15) | 0 |
Insomnia | 3 (17) | 0 | 1 (11) | 0 | 4 (15) | 0 |
Pneumonia | 3 (17) | 0 | 1 (11) | 0 | 4 (15) | 0 |
Hypertriglyceridemia | 2 (11) | 1 (6) | 1 (11) | 0 | 3 (11) | 1 (4) |
Diarrhea | 3 (17) | 0 | 0 | 0 | 3 (11) | 0 |
Pruritus | 3 (17) | 0 | 0 | 0 | 3 (11) | 0 |
Rash maculopapular | 3 (17) | 0 | 0 | 0 | 3 (11) | 0 |
Thrombocytopenia | 3 (17) | 0 | 0 | 0 | 3 (11) | 0 |
Nausea | 2 (11) | 0 | 1 (11) | 0 | 3 (11) | 0 |
Pyrexia | 2 (11) | 0 | 1 (11) | 0 | 3 (11) | 0 |
Purpura | 1 (6) | 0 | 2 (22) | 0 | 3 (11) | 0 |
Dry skin | 2 (11) | 0 | 0 | 0 | 2 (7) | 0 |
Joint pain | 2 (11) | 0 | 0 | 0 | 2 (7) | 0 |
Paronychia | 2 (11) | 0 | 0 | 0 | 2 (7) | 0 |
Upper respiratory tract infection | 2 (11) | 0 | 0 | 0 | 2 (7) | 0 |
Urinary tract infection | 2 (11) | 0 | 0 | 0 | 2 (7) | 0 |
Atrial fibrillation | 1 (6) | 0 | 1 (11) | 0 | 2 (7) | 0 |
Cataract | 1 (6) | 0 | 1 (11) | 0 | 2 (7) | 0 |
Epistaxis | 1 (6) | 0 | 1 (11) | 0 | 2 (7) | 0 |
Hyperkalemia | 1 (6) | 0 | 1 (11) | 0 | 2 (7) | 0 |
Indigestion | 1 (6) | 0 | 1 (11) | 0 | 2 (7) | 0 |
Pharyngitis | 1 (6) | 0 | 1 (11) | 0 | 2 (7) | 0 |
Weight decreased | 1 (6) | 0 | 1 (11) | 0 | 2 (7) | 0 |
Bronchitis | 0 | 0 | 2 (22) | 0 | 2 (7) | 0 |
Contusion | 0 | 0 | 2 (22) | 0 | 2 (7) | 0 |
Fall | 0 | 0 | 2 (22) | 0 | 2 (7) | 0 |
Anaphylactic reaction | 1 (6) | 1 (6) | 0 | 0 | 1 (4) | 1 (4) |
Atypical mycobacterial infection | 1 (6) | 1 (6) | 0 | 0 | 1 (4) | 1 (4) |
Erythema multiforme | 1 (6) | 1 (6) | 0 | 0 | 1 (4) | 1 (4) |
Increased lipase | 1 (6) | 1 (6) | 0 | 0 | 1 (4) | 1 (4) |
Rash erythematous | 1 (6) | 1 (6) | 0 | 0 | 1 (4) | 1 (4) |
Rhegmatogenous retinal detachment | 1 (6) | 1 (6) | 0 | 0 | 1 (4) | 1 (4) |
Type 2 diabetes | 0 | 0 | 1 (11) | 1 (11) | 1 (4) | 1 (4) |
Adverse events occurring in ≥2 patients and those with grade 3–4 are listed. Number (%) of patients is shown.