Table 2.
Adverse Events in Part B
| ELX/TEZ/IVA (N = 66) | |
|---|---|
| Any AE | 65 (98.5) |
| AE by maximum relatedness* | |
| Not related | 16 (24.2) |
| Unlikely related | 16 (24.2) |
| Possibly related | 29 (43.9) |
| Related | 4 (6.1) |
| AE by maximum severity* | |
| Mild | 36 (54.5) |
| Moderate | 28 (42.4) |
| Severe | 1 (1.5) |
| Serious AE | 1 (1.5) |
| AE leading to death | 0 |
| AE leading to discontinuation | 1 (1.5) |
| AE leading to interruption | 1 (1.5)† |
| Most common AEs‡ | |
| Cough | 28 (42.4) |
| Headache | 16 (24.2) |
| Pyrexia | 14 (21.2) |
| Oropharyngeal pain | 12 (18.2) |
| Upper respiratory tract infection | 11 (16.7) |
| Nasal congestion | 10 (15.2) |
| Rash | 8 (12.1) |
| Abdominal pain | 8 (12.1) |
| Rhinorrhea | 8 (12.1) |
| Viral upper respiratory tract infection | 8 (12.1) |
| Alanine aminotransferase increased | 7 (10.6) |
| Diarrhea | 7 (10.6) |
| Influenza | 7 (10.6) |
| Vomiting | 7 (10.6) |
Definition of abbreviations: AE = adverse event; ELX/TEZ/IVA = elexacaftor/tezacaftor/ivacaftor.
Data are presented as n (%).
A patient with multiple events within a category was counted only once in that category.
*
Relatedness to the trial regimen and severity were determined by the investigator observing the event.
†
The one AE leading to study drug interruption was because of diarrhea, vomiting, and fever.
‡
Only AEs that occurred in ⩾10% of the patients are listed; listing is according to the preferred term (Medical Dictionary for Regulatory Activities version 23.0).