Table 2

Frequency of occurrence of adverse events occurring in more than one subject in any VX-809 treatment group (listed alphabetically by MedRA term)

Adverse event, n (%)PlaceboVX-809 25 mgVX-809 50 mgVX-809 100 mgVX-809 200 mgTotal
(n=17)(n=18)(n=18)(n=17)(n=19)(n=45)
Cough7 (41.2)10 (55.6)6 (33.3)7 (41.2)10 (52.6)40 (88.9)
Headache3 (17.6)4 (22.2)5 (27.8)2 (11.8)5 (26.3)19 (42.2)
Rales1 (5.9)6 (33.3)2 (11.1)3 (17.6)3 (15.8)15 (33.3)
Productive cough3 (17.6)2 (11.1)04 (23.5)6 (31.6)15 (17.8)
Dyspnoea1 (5.9)5 (27.8)3 (16.7)2 (11.8)4 (21.1)15 (33.3)
Pulmonary exacerbation*2 (11.8)4 (22.2)2 (11.1)2 (11.8)4 (21.1)14 (31.1)
Fatigue2 (11.8)3 (16.7)3 (16.7)2 (11.8)3 (15.8)13 (28.9)
Fever2 (11.8)2 (11.1)1 (5.6)1 (5.9)5 (26.3)11 (24.4)
Nasal congestion3 (17.6)2 (11.1)1 (5.6)2 (11.8)2 (10.5)10 (22.2)
Wheezing3 (17.6)1 (5.6)4 (22.2)1 (5.9)09 (20)
Diarrhoea3 (17.6)3 (16.7)1 (5.6)2 (11.8)09 (20)
Oropharyngeal pain3 (17.6)03 (16.7)02 (10.5)8 (17.8)
Upper respiratory tract infection1 (5.9)2 (11.1)1 (5.6)3 (17.6)07 (15.6)
Sinus congestion2 (11.8)1 (5.6)2 (11.1)01 (5.3)6 (13.3)
Respiration abnormal01 (5.6)1 (5.6)04 (21.1)6 (13.3)
Haemoptysis2 (11.8)1 (5.6)1 (5.6)02 (10.5)6 (13.3)
Constipation02 (11.1)2 (11.1)1 (5.9)1 (5.3)6 (13.3)
Abdominal pain1 (5.9)3 (16.7)1 (5.6)01 (5.3)6 (13.3)
Myalgia1 (5.9)03 (16.7)01 (5.3)5 (11.1)
Post-tussive vomiting002 (11.1)1 (5.9)1 (5.3)4 (8.9)
Nausea03 (16.7)001 (5.3)4 (8.9)
Nasopharyngitis01 (5.6)01 (5.9)2 (10.5)4 (8.9)
Dizziness01 (5.6)02 (11.8)1 (5.3)4 (8.9)
Back pain02 (11.1)1 (5.6)01 (5.3)4 (8.9)
Abdominal pain upper1 (5.9)001 (5.9)2 (10.5)4 (8.9)
Sputum abnormal02 (11.1)001 (5.3)3 (6.7)
Epistaxis1 (5.9)0002 (10.5)3 (6.7)
C-reactive protein increased01 (5.6)02 (11.8)03 (6.7)
Paranasal sinus hypersecretion02 (11.1)0002 (4.4)
Lung hyperinflation0002 (11.8)02 (4.4)
  • * Physician-reported pulmonary exacerbation; coded as cystic fibrosis lung according to MedRA term.