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Table 4 Summary of treatment-emergent adverse events reported in ≥ 5% of patients in any treatment arm (Safety Set)

From: A randomized, double-blind, phase 2b study to investigate the efficacy, safety, tolerability and pharmacokinetics of a single-dose regimen of ferroquine with artefenomel in adults and children with uncomplicated Plasmodium falciparum malaria

Preferred term Artefenomel mg: Ferroquine mg
  800:400 800:600 800:900 800:1200 Total
N 92 94 96 91 373
At least 1 TEAE 84 (91.3) 87 (92.6) 85 (88.5) 81 (89.0) 337 (90.3)
Malaria 55 (59.8) 50 (53.2) 41 (42.7) 41 (45.1) 187 (50.1)
Vomiting 27 (29.3) 27 (28.7) 34 (35.4) 34 (37.4) 122 (32.7)
Cough 10 (10.9) 7 (7.4) 15 (15.6) 15 (16.5) 47 (12.6)
Upper Respiratory Tract Infection 7 (7.6) 6 (6.4) 17 (17.7) 10 (11.0) 40 (10.7)
Diarrhoea 10 (10.9) 11 (11.7) 7 (7.3) 11 (12.1) 39 (10.5)
Pyrexia 7 (7.6) 2 (2.1) 9 (9.4) 10 (11.0) 28 (7.5)
Electrocardiogram QT Prolongeda 6 (6.5) 5 (5.3) 6 (6.3) 8 (8.8) 25 (6.7)
Headache 6 (6.5) 7 (7.4) 7 (7.3) 5 (5.5) 25 (6.7)
Abdominal pain 7 (7.6) 5 (5.3) 5 (5.2) 6 (6.6) 23 (6.2)
Decreased Appetite 5 (5.4) 8 (8.5) 5 (5.2) 5 (5.5) 23 (6.2)
Bronchitis 3 (3.3) 5 (5.3) 4 (4.2) 5 (5.5) 17 (4.6)
Rhinitis 4 (4.3) 3 (3.2) 1 (1.0) 7 (7.7) 15 (4.0)
  1. MedDRA version 22.1. All doses of artefenomel and ferroquine are expressed as adult-equivalent doses
  2. Data presented are the number (%) of patients with at least 1 TEAE in the Safety Set
  3. TEAEs were AEs that developed or worsened or became serious during the on-treatment phase, i.e. time from the start of the first dose of study drug administration (included) up to the Day 63 visit (included)
  4. Table sorted by decreasing frequency of preferred term in pooled treatment arms
  5. aQTc prolongation was to be recorded as an AE (preferred term 'electrocardiogram QT prolonged') if it met any of the following criteria (i) symptomatic, (ii) requiring either corrective treatment or consultation, (iii) leading to treatment discontinuation or modification of dosing, (iv) fulfilling a seriousness criterion, (v) met the criteria for an AESI (QTcF ≥ 500 ms or QTcF prolongation > 60 ms from baseline)