Adverse events (AEs) and serious AEs (SAEs) reported during the study period, excluding decreased CD4+ T-cell counts, by zanolimumab dosage and CTCL stage
. | No. patients (no. events) . | |||
---|---|---|---|---|
280 mg zanolimumab . | 560 mg zanolimumab . | 980 mg zanolimumab . | ||
IB-IIA . | IIB-IVB . | IB-IIA . | IIB-IVB . | |
All AEs | 11 (48) | 13 (112) | 14 (62) | 9 (54) |
Non-SAEs | 11 (46) | 13 (106) | 14 (62) | 9 (47) |
Nonserious related AEs | 8 (30) | 12 (55) | 13 (46) | 8 (19) |
Grade 1 | 7 (22) | 12 (51) | 10 (24) | 6 (12) |
Grade 2 | 4 (7) | 3 (4) | 9 (18) | 4 (6) |
Grade 3 | 1 (1) | 0 (0) | 4 (4) | 1 (1) |
All SAEs | 2 (2) | 3 (6) | 0 (0) | 5 (7) |
Related SAEs | 0 (0) | 2 (3) | 0 (0) | 1 (2) |
Grade 1 | 0 (0) | 2 (2) | 0 (0) | 0 (0) |
Grade 2 | 0 (0) | 1 (1) | 0 (0) | 0 (0) |
Grade 3 | 0 (0) | 0 (0) | 0 (0) | 1 (2) |
. | No. patients (no. events) . | |||
---|---|---|---|---|
280 mg zanolimumab . | 560 mg zanolimumab . | 980 mg zanolimumab . | ||
IB-IIA . | IIB-IVB . | IB-IIA . | IIB-IVB . | |
All AEs | 11 (48) | 13 (112) | 14 (62) | 9 (54) |
Non-SAEs | 11 (46) | 13 (106) | 14 (62) | 9 (47) |
Nonserious related AEs | 8 (30) | 12 (55) | 13 (46) | 8 (19) |
Grade 1 | 7 (22) | 12 (51) | 10 (24) | 6 (12) |
Grade 2 | 4 (7) | 3 (4) | 9 (18) | 4 (6) |
Grade 3 | 1 (1) | 0 (0) | 4 (4) | 1 (1) |
All SAEs | 2 (2) | 3 (6) | 0 (0) | 5 (7) |
Related SAEs | 0 (0) | 2 (3) | 0 (0) | 1 (2) |
Grade 1 | 0 (0) | 2 (2) | 0 (0) | 0 (0) |
Grade 2 | 0 (0) | 1 (1) | 0 (0) | 0 (0) |
Grade 3 | 0 (0) | 0 (0) | 0 (0) | 1 (2) |
Grades 4 and 5 did not include any patients.