Table 3.
Overview of TEAEs
| Tezacaftor/Ivacaftor (n = 50) | Placebo (n = 47) | |
|---|---|---|
| Total no. of TEAEs | 124 | 155 |
| Participants with any TEAEs, n (%) | 37 (74.0) | 39 (83.0) |
| Participants with TEAEs related or possibly related to study druga | 10 (20.0) | 16 (34.0) |
| Participants with serious TEAEs, n (%) | 5 (10.0) | 9 (19.1) |
| Participants with serious TEAEs related to study druga | 0 | 1 (2.1) |
| Participants with TEAEs leading to treatment discontinuation, n (%) b | 2 (4.0) | 1 (2.1) |
| Participants with TEAEs leading to treatment interruption, n (%) | 1 (2.0) | 1 (2.1) |
| Participants with TEAEs leading to death, n (%) b | 1 (2.0) | 0 |
| Participants with TEAEs related to study drug leading to death | 0 | 0 |
| Participants with TEAEs by maximum severity, n (%) | ||
| Mild | 16 (32.0) | 20 (42.6) |
| Moderate | 18 (36.0) | 16 (34.0) |
| Severe | 2 (4.0) | 3 (6.4) |
| Life-threateningb | 1 (2.0) | 0 |
| Most frequent TEAEs (≥10% in any group) by preferred term, n (%) | ||
| Cough | 9 (18.0) | 8 (17.0) |
| Infective pulmonary exacerbation of cystic fibrosis | 7 (14.0) | 13 (27.7) |
| Headache | 6 (12.0) | 7 (14.9) |
| Nasopharyngitis | 6 (12.0) | 0 |
| Constipation | 5 (10.0) | 0 |
| Dyspnea | 5 (10.0) | 5 (10.6) |
| Abdominal pain upper | 4 (8.0) | 5 (10.6) |
| Sputum increased | 2 (4.0) | 5 (10.6) |
| SAEs by preferred term, n (%) | ||
| Infective pulmonary exacerbation of cystic fibrosis | 3 (6.0) | 7 (14.9) |
| Constipation | 1 (2.0) | 0 |
| Multiple organ dysfunction syndrome | 1 (2.0) | 0 |
| Sepsis | 1 (2.0) | 0 |
| Suicidal ideation | 1 (2.0) | 0 |
| Lower respiratory tract infection | 0 | 1 (2.1) |
| Musculoskeletal chest pain | 0 | 1 (2.1) |
| Pericardial effusion | 0 | 1 (2.1) |
| Pleuritic pain | 0 | 1 (2.1) |
SAE, serious adverse event; TEAE, treatment-emergent adverse event.
a
As deemed related or possibly related by the investigator.
b
Due to postinfluenza sepsis and multiple organ dysfunction syndrome, resulting in a fatal outcome deemed not related to study drug by the investigator.