Table 1 Incidence of adverse events by preferred term
Preferred term | 800 mg KAF156 + 1280 mg PPQ | 800 mg KAF156 | 1280 mg PPQ | Total |
|---|---|---|---|---|
N = 24 | N = 24 | N = 24 | N = 72 | |
n (%) | n (%) | n (%) | n (%) | |
Number of subjects with at least one AE | 21 (87.5) | 14 (58.3) | 19 (79.2) | 54 (75.0) |
Headache | 4 (16.7) | 5 (20.8) | 8 (33.3) | 17 (23.6) |
Nausea | 10 (41.7) | 3 (12.5) | 2 (8.3) | 15 (20.8) |
Upper respiratory tract infection | 6 (25.0) | 2 (8.3) | 7 (29.2) | 15 (20.8) |
Abdominal pain | 3 (12.5) | 1 (4.2) | 0 | 4 (5.6) |
Dizziness | 2 (8.3) | 0 | 2 (8.3) | 4 (5.6) |
Diarrhoea | 1 (4.2) | 1 (4.2) | 1 (4.2) | 3 (4.2) |
Dyspepsia | 1 (4.2) | 1 (4.2) | 1 (4.2) | 3 (4.2) |
Somnolence | 0 | 1 (4.2) | 2 (8.3) | 3 (4.2) |
Fatigue | 1 (4.2) | 0 | 1 (4.2) | 2 (2.8) |
Pyrexia | 0 | 0 | 2 (8.3) | 2 (2.8) |
Visual impairment | 1 (4.2) | 1 (4.2) | 0 | 2 (2.8) |
Vomiting | 1 (4.2) | 0 | 1 (4.2) | 2 (2.8) |
Abdominal discomfort | 1 (4.2) | 0 | 0 | 1 (1.4) |
Alanine aminotransferase increased | 0 | 1 (4.2) | 0 | 1 (1.4) |
Catheter site erythema | 0 | 1 (4.2) | 0 | 1 (1.4) |
Conjunctival haemorrhage | 0 | 1 (4.2) | 0 | 1 (1.4) |
Cough | 0 | 1 (4.2) | 0 | 1 (1.4) |
Dry skin | 0 | 0 | 1 (4.2) | 1 (1.4) |
Dyskinesia | 0 | 0 | 1 (4.2) | 1 (1.4) |
Foreign body | 1 (4.2) | 0 | 0 | 1 (1.4) |
Gastroenteritis | 0 | 1 (4.2) | 0 | 1 (1.4) |
Gastroesophageal reflux diseasea | 0 | 0 | 1 (4.2) | 1 (1.4) |
Infected bite | 1 (4.2) | 0 | 0 | 1 (1.4) |
Insomnia | 0 | 0 | 1 (4.2) | 1 (1.4) |
Ligament sprain | 1 (4.2) | 0 | 0 | 1 (1.4) |
Lymphadenopathy | 1 (4.2) | 0 | 0 | 1 (1.4) |
Muscle spasms | 0 | 0 | 1 (4.2) | 1 (1.4) |
Myalgia | 0 | 0 | 1 (4.2) | 1 (1.4) |
Neck pain | 1 (4.2) | 0 | 0 | 1 (1.4) |
Oropharyngeal pain | 0 | 0 | 1 (4.2) | 1 (1.4) |
Phlebitis | 0 | 1 (4.2) | 0 | 1 (1.4) |
Rash erythematous | 1 (4.2) | 0 | 0 | 1 (1.4) |
Sleep disorder | 0 | 0 | 1 (4.2) | 1 (1.4) |
Toothache | 0 | 0 | 1 (4.2) | 1 (1.4) |
Viral infection | 0 | 0 | 1 (4.2) | 1 (1.4) |