Table 4.
Summary of the safety results (safety analysis set)
| Double-blind | Overall after dosing with mogamulizumab | ||||
|---|---|---|---|---|---|
| Mogamulizumab arm | Placebo arm | Mogamulizumab arm | Placebo arm | Total | |
| n = 34 | n = 32 | n = 34 | na = 31 | na = 65 | |
| Patients with any TEAE | 34 (100.0) | 28 (87.5) | 34 (100.0) | 31 (100.0) | 65 (100.0) |
| Death | 1 (2.9) | 0 (0.0) | 1 (2.9) | 0 (0.0) | 1 (1.5) |
| Other serious TEAEs | 3 (8.8) | 3 (9.4) | 16 (47.1) | 10 (32.3) | 26 (40.0) |
| Other significant TEAEsb | 16 (47.1) | 4 (12.5) | 24 (70.6) | 19 (61.3) | 43 (66.2) |
Data are presented as the n (%) of patients
an was calculated based on the patients who received at least one dose of mogamulizumab. One patient in the placebo arm withdrew from the study because of a TEAE during the double-blind period
bTEAEs for which the action taken with mogamulizumab resulted in drug withdrawal, dose postponement, dose reduction, or dose interruption
TEAE treatment-emergent adverse event