TABLE 4.
Summary of treatment‐emergent adverse events in the multiple‐rising dose study
| n (%) | Placebo (n = 12) a | BI 705564 | ||||||
|---|---|---|---|---|---|---|---|---|
| 10 mg (n = 8) | 20 mg (n = 8) | 40 mg (n = 8) | 60 mg (n = 8) | 80 mg (n = 8) | 40 mg SPTG (n = 8) | Total (N = 48) | ||
| TEAEs | 7 (58) | 3 (38) | 2 (25) | 4 (50) | 5 (63) | 2 (25) | 7 (88) | 23 (48) |
| Drug‐related TEAEs | 3 (25) | 1 (13) | 0 | 4 (50) | 4 (50) | 1 (13) | 6 (75) | 16 (33) |
| TEAEs in ≥2 participants overall, system organ class/preferred term | ||||||||
| Nervous system disorders | 3 (25) | 2 (25) | 0 | 1 (13) | 1 (13) | 0 | 5 (63) | 9 (19) |
| Headache | 1 (8) | 2 (25) | 0 | 1 (13) | 0 | 0 | 4 (50) | 7 (15) |
| Dizziness | 0 | 0 | 0 | 0 | 1 (13) | 0 | 2 (25) | 3 (6) |
| Orthostatic intolerance | 1 (8) | 0 | 0 | 1 (13) | 0 | 0 | 0 | 1 (2) |
| Gastrointestinal disorders | 1 (8) | 1 (13) | 1 (13) | 3 (38) | 1 (13) | 0 | 3 (38) | 9 (19) |
| Diarrhoea | 0 | 0 | 0 | 1 (13) | 0 | 0 | 3 (38) | 4 (8) |
| Abdominal pain, upper | 0 | 0 | 0 | 0 | 1 (13) | 0 | 1 (13) | 2 (4) |
| Toothache | 0 | 0 | 1 (13) | 1 (13) | 0 | 0 | 0 | 2 (4) |
| Nausea | 1 (8) | 0 | 0 | 0 | 0 | 0 | 1 (13) | 1 (2) |
| Musculoskeletal and connective tissue disorders | 2 (17) | 0 | 0 | 1 (13) | 1 (13) | 0 | 2 (25) | 4 (8) |
| Myalgia | 0 | 0 | 0 | 0 | 0 | 0 | 2 (25) | 2 (4) |
| Back pain | 1 (8) | 0 | 0 | 1 (13) | 0 | 0 | 0 | 1 (2) |
| Arthralgia | 2 (17) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Vascular disorders | 1 (8) | 0 | 0 | 0 | 0 | 0 | 1 (13) | 1 (2) |
| Haematoma | 1 (8) | 0 | 0 | 0 | 0 | 0 | 1 (13) | 1 (2) |
| Infections and infestations | 2 (17) | 0 | 1 (13) | 1 (13) | 0 | 0 | 2 (25) | 4 (8) |
| Nasopharyngitis | 2 (17) | 0 | 0 | 0 | 0 | 0 | 2 (25) | 2 (4) |
| Herpes simplex | 0 | 0 | 1 (13) | 0 | 0 | 0 | 0 | 1 (2) |
| Urinary tract infection | 0 | 0 | 0 | 1 (13) | 0 | 0 | 0 | 1(2) |
| Injury, poisoning and procedural complications | 0 | 0 | 0 | 0 | 1 (13) | 1 (13) | 0 | 2 (4) |
| Respiratory, thoracic and mediastinal disorders | 0 | 0 | 0 | 0 | 0 | 0 | 3 (38) | 3 (6) |
| Oropharyngeal pain | 0 | 0 | 0 | 0 | 0 | 0 | 3 (38) | 3 (6) |
| Epistaxis | 0 | 0 | 0 | 0 | 0 | 0 | 2 (25) | 2 (4) |
| Skin and subcutaneous disorders | 0 | 0 | 0 | 1 (13) | 2 (25) | 0 | 2 (25) | 5 (10) |
| Petechiae | 0 | 0 | 0 | 0 | 2 (25) | 0 | 2 (25) | 4 (8) |
| General disorders and admin site conditions | 2 (17) | 0 | 0 | 0 | 0 | 1 (13) | 3 (38) | 4 (8) |
| Fatigue | 2 (17) | 0 | 0 | 0 | 0 | 1 (13) | 2 (25) | 3 (6) |
a
Includes all participants who received placebo in the trial; the participants who received placebo in the MRD cohort and those who received placebo in the SPTG were pooled (the treatment duration was 4 weeks in the SPTG compared with 2 weeks in the MRD cohort).
MRD, multiple rising dose; SPTG, skin prick test group; TEAE, treatment‐emergent adverse event.