Table 4.
Overview of Adverse Eventsa
| Category | Placebo |
VX-210 (3 mg) |
VX-210 (9 mg) |
Total |
|---|---|---|---|---|
| N = 29 |
N = 6 |
N = 32 |
N = 67 |
|
| n (%) | n (%) | n (%) | n (%) | |
| Patients with any AEs | 29 (100.0) | 6 (100.0) | 32 (100.0) | 67 (100.0) |
| Patients with AEs by maximum severity | ||||
| Mild | 2 (6.9) | 0 | 3 (9.4) | 5 (7.5) |
| Moderate | 11 (37.9) | 0 | 14 (43.8) | 25 (37.3) |
| Severe | 8 (27.6) | 4 (66.7) | 8 (25.0) | 20 (29.9) |
| Life-threatening | 8 (27.6) | 2 (33.3) | 7 (21.9) | 17 (25.4) |
| Patients with SAEs | 18 (62.1) | 6 (100.0) | 16 (50.0) | 40 (59.7) |
| Patients with AEs leading to death | 0b | 1 (16.7) | 2 (6.3) | 3 (4.5)b |
| Most common AEsc | ||||
| Urinary tract infection | 20 (69.0) | 4 (66.7) | 20 (62.5) | 44 (65.7) |
| Pyrexia | 13 (44.8) | 3 (50.0) | 17 (53.1) | 33 (49.3) |
| Decubitus ulcer | 11 (37.9) | 4 (66.7) | 15 (46.9) | 30 (44.8) |
| Pneumonia | 9 (31.0) | 5 (83.3) | 15 (46.9) | 29 (43.3) |
| Muscle spasms | 9 (31.0) | 3 (50.0) | 14 (43.8) | 26 (38.8) |
| Insomnia | 11 (37.9) | 2 (33.3) | 9 (28.1) | 22 (32.8) |
| Hypotension | 10 (34.5) | 0 | 11 (34.4) | 21 (31.3) |
| Neuralgia | 7 (24.1) | 2 (33.3) | 10 (31.3) | 19 (28.4) |
| Anemia | 8 (27.6) | 2 (33.3) | 6 (18.8) | 16 (23.9) |
| Anxiety | 6 (20.7) | 1 (16.7) | 9 (28.1) | 16 (23.9) |
| Nausea | 7 (24.1) | 3 (50.0) | 5 (15.6) | 15 (22.4) |
| Depression | 7 (24.1) | 1 (16.7) | 6 (18.8) | 14 (20.9) |
| Neurogenic bladder | 5 (17.2) | 0 | 8 (25.0) | 13 (19.4) |
| Bradycardia | 7 (24.1) | 1 (16.7) | 4 (12.5) | 12 (17.9) |
| Constipation | 4 (13.8) | 0 | 7 (21.9) | 11 (16.4) |
| Musculoskeletal pain | 5 (17.2) | 1 (16.7) | 5 (15.6) | 11 (16.4) |
n indicates number of patients with AEs in the corresponding category; N indicates number of patients dosed.
AE data were coded using Medical Dictionary for Regulatory Activities Version 21.1. Most common AEs are listed by preferred term in descending order of total. A patient with multiple events within a category was counted only once within that category.
One patient in the placebo group died during the study (unknown cause, 9 months after the patient received placebo). The event occurred outside the protocol-defined treatment-emergent period (28 days after treatment/the last available visit) for patients who do not complete the follow-up visits, as was the case with this patient.
AEs occurring in ≥15% of total patient population.
AE, adverse event; SAE, serious adverse event.