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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