Table 3.
Incidence of TEAE and SAEs at 18 months in the ITT population
| Number of patients (N=230) | Number of events | |
|---|---|---|
| At least one adverse event | 214 (93%) | 1280 |
| At least one TEAE | 214 (93%) | 1261 |
| At least one TEAE during the treatment period | 212 (92%) | 1166 |
| At least one TEAE after the treatment period | 63 (27%) | 95 |
| At least one TEAE leading to treatment discontinuation (temporary or permanent) | 0 | .. |
| At least one TEAE leading to permanent treatment discontinuation | 0 | .. |
| At least one mild or moderate TEAE | 214 (93%) | 1219 |
| At least one severe TEAE | 28 (12%) | 41 |
| At least one TEAE possibly related to treatment | 195 (85%) | 860 |
| At least one SAE | 23 (10%) | 38 |
| At least one TESAE | 22 (10%) | 34 |
| At least one TESAE during the treatment period | 1 (<1%) | 1 |
| At least one TESAE after treatment period | 21 (9%) | 33 |
| At least one TESAE leading to treatment discontinuation (temporary or permanent) | 0 | .. |
| At least one TESAE leading to permanent treatment discontinuation | 0 | .. |
| At least one TESAE possibly related to treatment | 2 (1%) | 2 |
| At least one TESAE leading to death | 4 (2%) | 4 |
ITT=intention to treat. SAE=serious adverse event. TEAE=treatment-emergent adverse event. TESAE=treatment-emergent serious adverse event.