Table 4.
Number of AEs in both treatment groups and their intensity, classified and sorted according to system organ class (SOC) for the ITT set
| SOC | Total | PIO |
PLA |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| intensity of AE |
total | intensity of AE |
total | ||||||||
| mild | mod. | sev. | NA | mild | mod. | sev. | NA | ||||
| Gastrointestinal disorders | 20 | 6 | 1 | 0 | 0 | 7 | 10 | 3 | 0 | 0 | 13 |
| Investigations | 18 | 7 | 2 | 0 | 0 | 9 | 3 | 5 | 1 | 0 | 9 |
| Infections and infestations | 17 | 4 | 4 | 0 | 0 | 8 | 6 | 3 | 0 | 0 | 9 |
| Musculoskeletal and connective tissue disorders | 17 | 5 | 3 | 0 | 0 | 8 | 5 | 3 | 1 | 0 | 9 |
| Injury, poisoning and procedural complications | 14 | 3 | 5 | 0 | 0 | 8 | 3 | 2 | 1 | 0 | 6 |
| Metabolism and nutrition disorders | 11 | 5 | 0 | 0 | 0 | 5 | 4 | 2 | 0 | 0 | 6 |
| Vascular disorders | 9 | 1 | 4 | 1 | 0 | 6 | 0 | 2 | 1 | 0 | 3 |
| Cardiac disorders | 7 | 1 | 1 | 0 | 0 | 2 | 3 | 2 | 0 | 0 | 5 |
| Nervous system disorders | 4 | 2 | 0 | 0 | 0 | 2 | 2 | 0 | 0 | 0 | 2 |
| Skin and subcutaneous tissue disorders | 4 | 2 | 0 | 0 | 0 | 2 | 2 | 0 | 0 | 0 | 2 |
| General disorders and administration site conditions | 3 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 3 |
| Eye disorders | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| Surgical and medical procedures | 2 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 |
| Blood and lymphatic system disorders | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Total | 129 | 37 | 23 | 1 | 0 | 61 | 41 | 22 | 5 | 0 | 68 |
mod. = Moderate; sev. = severe; NA = not available.