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. 2009 Dec 10;8:289. doi: 10.1186/1475-2875-8-289

Table 1.

main characteristics of 35 cases of fatal outcome from cardiac origin presumably related to halofantrine

patient agea (year) Median: 27; range: 2 - 53
sexb male: n = 9 (27%); female: n = 24 (70%)

geographic origin of patients developing world, n = 25; developed world, n = 10

type of report  • spontaneous n = 34
 • clinical trial n = 0
(GSK data base only)  • post marketing survey n = 0

source of report health care professional n = 35

time from first dose to death (day) median: 1; range: 0 3
 • same day as first dose: n = 13 (37%)
 • 1 day after first dose: n = 13 (37%)
 • 2 days after first dose: n = 2 (6%)
 • 3 days after first dose: n = 3 (8%)
 • unknown: n = 4 (11%)

number of patients receiving 1 or 2 courses of halofantrive and number of doses taken by patientsc  • first course of halofantrine: n = 23
  ◦ 1 dose: n = 1 (3%)
  ◦ 2 doses: n = 9 (26%)
  ◦ 3 doses: n = 10 (28%)
  ◦ other including pediatric formulation: n = 3
 • second course of halofantrine: n = 6
  ◦ 5 or 6 doses: n = 5 (14%)
  ◦ 8 doses: n = 1 (3%)

malaria diagnosis and malaria  • no diagnostic test performed: n = 8
speciesd  • blood smear negative: n = 7
 • P. falciparum: n = 8
 • P. vivax: n = 1
 • Plasmodium sp: n = 4

concomitant drugs with possible cardiac effect n = 20 (57%)
 • anti-malarial: chloroquine: n = 7; mefloquine: n = 4; amodiaquine: n = 1;
 • antibiotics: cyclines, n = 2; metronidazole, n = 1; ciprofloxacine, n = 1; norfloxacine, n = 1
 • drugs leading to electrolyte imbalance: diuretics, n = 2; potassium, n = 1

underlying medical condition n = 14 (40%)
 • cardiovascular disease, n = 11
 • obesity, n = 1
 • epilepsy, n = 1
 • severe anaemia, n = 1

missing data: a: n = 3; b: n = 2; c: 6; d: n = 7