Table 3.
Summary of treatment‐emergent adverse events by system organ class and preferred term (in at least two patients)
| Rilzabrutinib (n = 27) | Independent of causality | Treatment relateda |
|---|---|---|
| Any treatment‐emergent adverse event | 20 (74) | 12 (44) |
| Gastrointestinal disorders | 11 (41) | 7 (26) |
| Nausea | 6 (22) | 4 (15) |
| Upper abdominal pain | 3 (11) | 3 (11) |
| Diarrhoea | 3 (11) | 2 (7) |
| Dry mouth | 2 (7) | 2 (7) |
| Vomiting | 2 (7) | 1 (4) |
| Abdominal pain | 2 (7) | 0 |
| Nervous system disorders | 10 (37) | 6 (22) |
| Headache | 4 (15) | 2 (7) |
| Dizziness | 2 (7) | 1 (4) |
| Paraesthesia | 2 (7) | 0 |
| Infections and infestationsb | 10 (37) | 3 (11)b |
| Upper respiratory infection | 2 (7) | 2 (7) |
| Staphylococcal skin infection | 2 (7) | 0 |
| General disorders or administration‐site conditions | 7 (26) | 2 (7) |
| Fatigue | 2 (7) | 1 (4) |
| Peripheral swelling | 2 (7) | 0 |
| Musculoskeletal and connective tissue disorders | 7 (26) | 2 (7) |
| Arthralgia | 2 (7) | 1 (4) |
| Pain in extremity | 2 (7) | 1 (4) |
| Muscle spasms | 2 (7) | 0 |
| Respiratory, thoracic and mediastinal disorders | 4 (15) | 2 (7) |
| Epistaxis | 2 (7) | 2 (7) |
| Ear and labyrinth disorders | 3 (11) | 2 (7) |
| Vertigo | 2 (7) | 1 (4) |
| Psychiatric disorders | 2 (7) | 0 |
| Anxiety | 2 (7) | 0 |
| Skin and subcutaneous tissue disorders | 2 (7) | 2 (7) |
| Erythema | 2 (7) | 2 (7) |
Values are n (%). Data cutoff 5 March 2020. aAll were grade 1 or 2 unless noted otherwise. bOne patient had a treatment‐related serious adverse event (grade 3 cellulitis of the leg). Treatment with rilzabrutinib at 400 mg twice daily was briefly interrupted and was resumed for a further 2 months without event recurrence and the patient completed the study.