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Table 5 Summary of adverse events by time since primaquine dosing

From: Safety of single-dose primaquine as a Plasmodium falciparum gametocytocide: a systematic review and meta-analysis of individual patient data

 

Controlled studies

Uncontrolled studies

Total

Primaquine, N [%] with AE

No primaquine, N [%] with AE

OR (95% CI)a

P-value

Primaquined, N [%] with AE

Primaquine, N [%] with AE

By day 28

7 studies

896 participants

7 studies

403 participants

  

2 studies

139 participants

9 studies

1035 participants

 Any SAE

14 [1.6]

5 [1.2]

1.41 (0.48–4.18)

0.535

0 [0]

14 [1.4]

 Any AE ≥ grade 2b

44 [11.5]

36 [15.8]

0.78 (0.47–1.29)

0.330

9 [6.5]

53 [5.1]

By day 7

8 studies

1143 participants

8 studies

516 participants

  

4 studies

1970 participants

12 studies

3113 participants

 Any AE

238 [20.8]

99 [19.2]

1.31 (0.99–1.74)

0.062

35 [1.8]

273 [8.8]

 Any SAE

10 [0.9]

4 [0.8]

1.35 (0.39–4.65)

0.635

1 [0.1]

11 [0.4]

 Haematological SAE

8 [0.7]

4 [0.8]

1.14 (0.31–4.12)

0.845

1 [0.1]

9 [0.3]

 Any AE ≥ grade 2b

48 [7.6]

35 [10.3]

0.90 (0.55–1.45)

0.655

13 [0.7]

61 [2.0]

 Vomiting

14 [1.2]

10 [1.9]

0.88 (0.37–2.06)

0.761

2 [0.1]

16 [0.5]

 Headache

57 [5.0]

20 [3.9]

1.26 (0.73–2.16)

0.408

6 [0.3]

63 [2.0]

 Pyrexia

45 [3.9]

29 [5.6]

0.96 (0.58–1.61)

0.882

1 [0.1]

46 [1.5]

 Abdominal pain

29 [2.5]

11 [2.1]

1.42 (0.68–2.96)

0.347

0 [0]

29 [0.9]

 Any gastrointestinal

52 [4.5]

25 [4.8]

1.19 (0.70–2.01)

0.514

4 [0.2]

56 [1.8]

By day 3

8 studies

1143 participants

8 studies

516 participants

  

4 studies

1970 participants

12 studies

3113 participants

 Any AE

166 [14.5]

76 [14.7]

1.37 (0.99–1.91)

0.061

23 [1.2]

189 [6.1]

 Any SAE

8 [0.7]

4 [0.8]

1.15 (0.32–4.10)

0.834

1 [0.1]

9 [0.3]

 Haematological SAE

6 [0.5]

4 [0.8]

0.93 (0.24–3.58)

0.917

1 [0.1]

7 [0.2]

 Any AE ≥ grade 2b

37 [5.9]

31 [9.1]

0.83 (0.49–1.42)

0.498

9 [0.5]

46 [1.5]

 Haemoglobinuriac

39 [2.6]

13 [1.9]

2.39 (1.22–4.67)

0.011

1 [0.1]

53 [1.8]

 Vomiting

13 [1.1]

10 [1.9]

0.83 (0.35–1.98)

0.676

2 [0.1]

15 [0.5]

 Headache

35 [3.1]

15 [2.9]

1.09 (0.57–2.07)

0.792

4 [0.2]

39 [1.3]

 Pyrexia

34 [3.0]

25 [4.8]

0.97 (0.55–1.72)

0.928

1 [0.1]

35 [1.1]

 Abdominal pain

19 [1.7]

8 [1.6]

1.56 (0.65–3.73)

0.321

0 [0]

19 [0.6]

 Any gastrointestinal

40 [3.5]

21 [4.1]

1.24 (0.69–2.23)

0.464

2 [0.1]

42 [1.3]

  1. N number of participants
  2. aAdjusted for study site
  3. bGrading not available for one study (ID 2) with 288 AEs and a further 30 AEs from another 2 studies, all RCTs (primaquine: day 28, 145; day 7, 85; day 3, 39; no-primquine: day 28, 48; day 7, 27; day 3, 11)
  4. cEight studies had haemoglobinuria data in controlled studies, 1516 participants in the primaquine arm and 680 in the no primaquine arm. These data include 19 records of haemoglobinuria that were not reported as AEs. One study with 813 participants had haemoglobinuria data in uncontrolled studies. There was no haemoglobinuria reported after day 3
  5. dExact day of SAE within 7 days of follow-up not known for one haematological SAE in uncontrolled studies
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BMC Medicine

ISSN: 1741-7015

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