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Table 4 Detailed summary of adverse events and serious adverse events* as reported after exposure to SLD PQ together with AL

From: Development of a pharmacovigilance safety monitoring tool for the rollout of single low-dose primaquine and artemether-lumefantrine to treat Plasmodium falciparum infections in Swaziland: a pilot study

Sex Age (years) Baseline Hb (g/dL) Follow-up Hb (g/dL) Adverse event Severity grade Actions taken Outcome
Male 32 14.9 13.2 Dark urine Moderate Urinalysis and CBC Recovered
Male 28 15.7 15.8 Dark urine Moderate None Recovered
Female 63 12.6 9.6 Unwell (worsening post-dose) Moderate None Unknown
Female 18 9.2 Anaemia, back pain, fever, and vomiting after meals Moderate Prescribed drug Recovered
*Female 31 14.1 12.5 Diarrhoea, vomiting, headache, and dizziness Moderate Hospitalization Recovered
Male 5 9.3 8.0 Dark urine (grade: 8) Severe None Recovered
Female 30 14.9 13.6 Nausea Moderate None Recovered
*Male 60 12.8 Fever, chills, diarrhoea and vomiting N/A Prescribed drug Fatal
Male 44 9.8 11.2 Dark urine (grade: 5) Mild None Recovered
*Malea 28 19.5 Weak, jaundice, coughing N/A Prescribed drug Fatal
Female 3 10.5 11.6 Stomach cramps Mild Unknown Recovered
  1. Dashes represent missing values
  2. AL artemether-lumefantrine, CBC complete blood count, Hb haemoglobin, N/A not applicable, SLD PQ single low-dose primaquine
  3. aReceived anti-malarial treatment despite testing negative for malaria by rapid diagnostic test and microscopy