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Table 1 Incidence of adverse events by preferred term

From: A phase 1 evaluation of the pharmacokinetic/pharmacodynamic interaction of the anti-malarial agents KAF156 and piperaquine

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)
  1. A subject with multiple adverse events (AEs) is counted only once in the “at least one AE” row
  2. A subject with multiple AEs with the same preferred term is counted only once for that preferred term & treatment
  3. Preferred terms are sorted in descending frequency
  4. aReflux oesophagitis began before dosing but was exacerbated following dosing and labelled ‘drug-related’
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Malaria Journal

ISSN: 1475-2875

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