Skip to main content

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