Table 8 Summary of study AEs and SAEs
AE description | Patients (N = 55), n (%) | Events, n |
|---|---|---|
At least one AE | 49 (89.1) | 497 |
At least one AE related to disease progression | 41 (74.5) | 230 |
At least one AE related to treatment | 6 (10.9) | 20 |
At least one AE related to study procedures | 5 (9.1) | 12 |
At least one life-threatening AE | 0 | 0 |
Deaths | 0 | 0 |
Most common AEs (occurring in > 10% of patients) | ||
Pyrexia | 14 (25.5) | 20 |
Upper respiratory tract infection | 12 (21.8) | 19 |
Diarrhea | 10 (18.2) | 15 |
Carpal tunnel syndrome | 10 (18.2) | 12 |
Nasopharyngitis | 9 (16.4) | 16 |
Vomiting | 9 (16.4) | 12 |
Pain in extremity | 8 (14.5) | 8 |
Cough | 7 (12.7) | 10 |
Ear infection | 7 (12.7) | 10 |
Mitral valve incompetence | 7 (12.7) | 8 |
Aortic valve disease | 7 (12.7) | 7 |
Enlarged cerebral perivascular spaces | 6 (10.9) | 6 |
Otitis media | 6 (10.9) | 10 |
Most common SAEs (occurring in two or more patients) | ||
Device-related infection | 2 (3.6) | 3 |