TABLE 2.
Overview of TEAE by severity and relation to study medication
| Parameter | PD01A (n = 12) | PD03A (n = 12) | Placebo (n = 6) | Total (n = 30) | |
|---|---|---|---|---|---|
| All TEAE | Subjects (events) | 11 (231) | 12 (217) | 6 (147) | 29 (595) |
| Mild TEAE | 11 (116) | 12 (108) | 6 (101) | 29 (325) | |
| Moderate TEAE | 11 (94) | 11 (92) | 6 (41) | 28 (227) | |
| Severe TEAE | 8 (19) | 7 (16) | 2 (5) | 17 (40) | |
| Fatal events | 2 (2) | 1 (1) | 0 | 3 (3) | |
| SAE | 7 (10) | 2 (2) | 2 (3) | 11 (15) | |
| Treatment‐related AE | Subjects (events) | 11 (109) | 10 (97) | 6 (71) | 27 (277) |
| Unrelated AE | 11 (122) | 12 (120) | 6 (76) | 29 (318) |
AE, adverse event; treatment‐related AE, AE classified as possibly, probably, or certainly related to the IMP; SAE, serious adverse event; TEAE, treatment‐emergent AE; data from ITT population.