Table 2.
Cumulative incidence of 15 most common adverse events among the four CFTR modulators currently available in clinical practice.
| Event | IVA (n = 483) | LUM-IVA (n = 1111) | TEZ-IVA (n = 607) | ELX-TEZ-IVA (n = 276) |
|---|---|---|---|---|
| Number of Patients (Percent) | ||||
| PEX | 104 (21.5%) | 355 (31.9%) | 137 (22.6%) | 59 (21.4%) |
| Cough | 102 (21.1%) | 224 (20.2%) | 134 (22.1%) | 57 (20.6%) |
| Oropharyngeal pain | 46 (9.5%) | 94 (8.5%) | 31 (5.1%) | 20 (7.2%) |
| Increased sputum | 44 (9.1%) | 166 (14.9%) | 62 (10.2%) | 60 (21.7%) |
| Nasal congestion | 43 (8.9%) | 82 (7.4%) | 16 (2.6%) | 0 |
| Headache | 44 (9.1%) | 140 (12.6%) | 79 (13%) | 35 (12.7%) |
| Upper respiratory tract infection | 43 (8.9%) | 78 (7%) | 0 | 24 (8.7%) |
| Hemoptysis | 26 (5.7%) | 121 (10.9%) | 38 (6.3%) | 11 (4%) |
| Dyspnea | 4 (0.8%) | 126 (11.3%) | 9 (1.5%) | 0 |
| Chest tightness | 0 | 104 (9.4%) | 0 | 0 |
| Abdominal pain | 34 (7%) | 28 (2.5%) | 10 (1.6%) | 0 |
| Fatigue | 34 (7%) | 9 (0.8%) | 35 (5.8%) | 9 (3.2%) |
| Pyrexia | 34 (7%) | 30 (2.7%) | 50 (8.2%) | 9 (3.2%) |
| Diarrhea | 29 (6%) | 99 (8.9%) | 19 (3.1%) | 26 (9.4%) |
| Increased AST or ALT > 3 ULN or increased bilirubin > 1.5 ULN | 39 (8.1%) | 81 (7.3%) | 29 (4.8%) | 54 (19.6%) |
Definitions: PEX: pulmonary exacerbations; ULN: upper level of normality.