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Table 3 Risk factors for the change in haemoglobin concentration on day 7 following ACT first dose administration

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

Parameter

Absolute change in haemoglobin concentration

Fractional drop > 25% compared to baseline levels

Na

change (g/dL)

95% CI

P-value

na

AOR

95% CI

P-value

Age/sex category

 < 5 years

733

− 0.82

− 0.99, − 0.66

< 0.001

27

6.20

2.73, 14.12

< 0.001

 5–11 years

1561

− 0.57

− 0.70, − 0.45

< 0.001

35

2.70

1.32, 5.50

0.006

 12+ years females

612

− 0.60

− 0.72, − 0.47

< 0.001

28

3.20

1.67, 6.13

< 0.001

 12+ males

969

0.00

  

22

1.00

  

Transmission intensityb

 Low

2444

− 0.40

− 0.90, 0.10

0.117

96

4.20

1.41, 12.51

0.010

 Moderate

769

− 0.38

− 0.62, − 0.14

0.003

11

1.64

0.47, 5.78

0.438

 High

662

0.00

  

5

1.00

  

Pf malaria status

 Yes

2462

− 0.72

− 1.20, − 0.24

0.003

    

 No or unknownc

1413

0.00

      

Log 10 parasitaemia

3875

Nonlineard

< 0.001

    

Haemoglobin (g/dL)

3875

Nonlineare

< 0.001

112

 

Nonlineare

< 0.001

G6PD status

 Normal

3170

0.00

  

78

1.00

  

 Deficient

194

− 0.03

− 0.30, 0.24

0.834

20

1.45

0.51, 4.16

0.486

 Unknown

511

− 0.14

− 0.40, 0.13

0.312

14

0.24

0.04, 1.59

0.140

Primaquine dose (0.1 mg/kg)f

 Normal G6PD status

2265

− 0.01

− 0.03, 0.01

0.334

55

1.06

0.98, 1.15

0.162

 G6PD deficient

127

− 0.27g

− 0.34, − 0.19

< 0.001

18

1.63h

1.32, 2.01

< 0.001

 G6PD status unknown

389

− 0.01

− 0.05, 0.03

0.732

14

1.36

1.04, 1.78

0.026

 

Moderate/severe anaemia (Hb < 10 g/dL)

Severe anaemia (Hb < 7 g/dL)i

na

AOR

95% CI

P-value

na

AOR

95% CI

P-value

Age/sex category

 < 5 years

294

3.52

2.18, 5.68

< 0.001

    

 -11 years

234

1.89

1.23, 2.92

0.004

    

 2+ years: females

68

1.35

0.85, 2.16

0.209

    

 12+ years: males

43

1.00

      

Log 10 parasitaemia (/μL)

639

Nonlineard

< 0.001

    

Haemoglobin (g/dL)

639

Nonlineare

< 0.001

35

Nonlineare

< 0.001

G6PD status

 Normal

533

Reference

      

 Deficient

44

0.99

0.43, 2.24

0.974

    

 Unknown

62

0.66

0.27, 1.62

0.368

    

Primaquine dose (per 0.1 mg/kg increase)f

 Normal G6PD status

403

1.04

1.00, 1.09

0.079

9

1.19

0.99, 1.42

0.059

 G6PD deficient

33

1.60k

1.28, 1.99

< 0.001

6

1.89l

1.49, 2.40

< 0.001

 G6PD status unknown

47

1.07

0.94, 1.23

0.291

7

1.34

1.09, 1.65

0.005

  1. Multivariable regression models (logistic or normal, as appropriate) with a random intercept for the study site were fitted. Random coefficient models (for primaquine dose) could not be reliably evaluated for binary outcomes and for the absolute change in Hb concentration in patients with G6PD deficiency due to small numbers. For the absolute change in Hb concentration in patients without G6PD deficiency, a random coefficient model has not improved the fit significantly and provided similar population estimates, with a population mean = 0.03 (95% CI − 0.03, 0.10) and standard deviation = 0.103 (95% CI 0.056, 0.190) for the random slope for primaquine dose (0.1mg/kg)
  2. aN = number of observations in that category and n = number of patients in that category with FC < − 25% or moderate or severe anaemia, respectively
  3. bTransmission intensity defined based on estimates of P. falciparum prevalence rate (PfPR), assuming low transmission for study sites with a PfPR < 0.15, moderate transmission if PfPR 0.15 to < 0.40, and high transmission if PfPR ≥ 0.40
  4. cIncludes individuals with no malaria (n = 224), malaria-positive or gametocytaemic at screening (n = 564), and symptomatic individuals from the community who were not tested (n = 625)
  5. dFor nonlinear relationship, see Additional file 3: Fig. S5
  6. eFor nonlinear relationship, see Fig. 2
  7. fN and n, defined as before but refer to individuals who received primaquine in that category
  8. gChange in Hb = − 0.528, (95% CI − 0.887, − 0.168), P = 0.004, for comparison of 0.25 mg/kg primaquine (83) and no primaquine arms (67) in patients with G6PD deficiency
  9. hAOR = 3.98, (95% CI 0.77, 20.59), P = 0.099, for comparison of 0.25 mg/kg primaquine (8/83) and no primaquine arms (2/67) in patients with G6PD deficiency, only adjusted for haemoglobin due to small numbers
  10. iAdjusted only for baseline haemoglobin levels due to small numbers
  11. kAOR = 3.25, (95% CI 0.96, 10.95), P = 0.057, for comparison of 0.25 mg/kg primaquine (17/83) and no primaquine arms (11/67) in patients with G6PD deficiency
  12. lAOR = 10.36, (95% CI 0.28, 389.51), P = 0.206 for comparison of 0.25 mg/kg primaquine (2/83) and no primaquine (1/67) arms in patients with G6PD deficiency, not adjusted for the site due to small number of events observed
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BMC Medicine

ISSN: 1741-7015

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