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Table 4 Safety of trial interventions: adverse events

From: Sulphadoxine-pyrimethamine plus azithromycin for the prevention of low birthweight in Papua New Guinea: a randomised controlled trial

Outcome

Control (SPCQ and placebo) n = 1,374

Intervention (SPAZ) n = 1,378

Risk ratio (95% CI)

P

All adverse events

414

(30.1)

397

(28.8)

0.96 (0.85–1.07)

0.447

All serious adverse events (SAE)

174

(12.7)

181

(13.1)

1.04 (0.85–1.26)

0.712

Maternal a

100

(7.3)

104

(7.5)

1.04 (0.80–1.35)

0.788

No. admittedb

94

(6.8)

90

(6.5)

0.96 (0.72–1.26)

0.745

No. of mothers with 2 SAEs

4

(0.3)

1

(0.1)

0.25 (0.03–2.23)

0.218

No. drug-related SAEs

0

(0.0)

0

(0.0)

–

–

Characteristics of maternal SAEs c

      

  Maternal death

1

(0.1)

2

(0.2)

1.99 (0.18–22.0)

>0.999

  Spontaneous abortion

4

(0.3)

1

(0.1)

0.24 (0.03–2.23)

0.218

  Stillbirth

15

(1.1)

25

(1.8)

1.66 (0.88–3.14)

0.113

  Emergency caesarean section

24

(1.8)

24

(1.7)

1.00 (0.57–1.75)

0.992

  Hypertensive disorders of pregnancy

11

(0.8)

12

(0.9)

1.09 (0.48–2.46)

>0.999

  Malaria

6

(0.4)

3

(0.2)

0.50 (0.12–1.99)

0.314

  Other infections

10

(0.8)

6

(0.4)

0.60 (0.22–1.64)

0.330

  Anaemia

3

(0.2)

2

(0.2)

0.66 (0.11–3.97)

0.687

  Placenta praevia

2

(0.2)

3

(0.2)

1.50 (0.25–8.94)

>0.999

  Antepartum haemorrhage

3

(0.2)

4

(0.3)

1.33 (0.30–5.93)

>0.999

  Preterm labour

16

(1.2)

6

(0.4)

0.31 (0.11–0.85)

0.034

  Preterm premature rupture of membranes

13

(1.0)

4

(0.3)

0.31 (0.10–0.94)

0.030

  Prolonged prelabour rupture of membranes

2

(0.2)

1

(0.1)

0.50 (0.05–5.49)

0.624

  Induction of labour (post-dates)

0

(0.0)

4

(0.3)

–

0.125

  Postpartum haemorrhage

16

(1.2)

23

(1.7)

1.43 (0.76–2.70)

0.333

  Otherd

3

(0.2)

3

(0.2)

1.00 (0.20–4.93)

>0.999

Neonatal

74

(5.4)

77

(5.6)

1.04 (0.76–1.42)

0.816

  No. admittedb

61

(4.4)

67

(4.9)

1.10 (0.78–1.54)

0.599

  No. of babies with two SAEs

0

(0.0)

1

(0.0)

–

>0.999

  No. drug-related SAEs

0

(0.0)

0

(0.0)

–

-

Characteristics of neonatal SAEs c

      

  Congenital abnormalitye

8

(0.6)

10

(0.7)

1.25 (0.49–3.14)

0.814

  Neonatal death

19

(1.4)

11

(0.8)

0.58 (0.28–1.21)

0.140

  Prematurity

15

(1.1)

9

(0.7)

0.60 (0.26–1.36)

0.227

  Low birthweight

20

(1.5)

10

(0.7)

0.50 (0.23–1.06)

0.069

  Infection

42

(3.1)

37

(2.7)

0.88 (0.57–1.36)

0.570

  Birth asphyxia

16

(1.2)

18

(1.3)

1.12 (0.57–2.19)

0.736

  Meconium aspiration syndrome

10

(0.7)

14

(1.0)

1.40 (0.62–3.13)

0.416

  Cephalohaematoma

3

(0.2)

6

(0.4)

1.99 (0.50–7.96)

0.507

  Jaundice

2

(0.2)

3

(0.2)

1.50 (0.25–8.94)

>0.999

All non-serious adverse events (AEs)

240

(17.5)

216

(15.7)

0.94 (0.80–1.11)

0.456

  No. women with two AEs

10

(0.7)

13

(0.9)

1.30 (0.57–2.95)

0.535

  No. drug-related maternal AEf

149

(10.8)

144

(10.5)

0.96 (0.78–1.20)

0.737

  No. drug-related formal withdrawalsg

7

(0.5)

8

(0.6)

1.14 (0.41–3.13)

>0.999

  No. women with two drug-related AEs

3

(0.2)

9

(0.7)

2.99 (0.81–11.03)

0.145

Characteristics of drug-related maternal AEs

      

  Vomiting

82

(6.0)

74

(5.4)

0.90 (0.66–1.22)

0.498

  Dizziness

56

(4.1)

33

(2.4)

0.59 (0.39–0.90)

0.013

  Nausea

37

(2.7)

43

(3.1)

1.16 (0.75–1.79)

0.544

  Pruritus

17

(1.2)

9

(0.7)

0.53 (0.24–1.18)

0.120

  Weakness

13

(1.0)

13

(0.9)

1.00 (0.46–2.14)

0.994

  Abdominal pain

3

(0.2)

12

(0.9)

4.32 (1.23–15.13)

0.021

  Headache

8

(0.6)

5

(0.4)

0.62 (0.20–1.90)

0.422

  Diarrhoea

1

(0.1)

3

(0.2)

2.99 (0.31–28.7)

0.625

  Facial swelling (mild)

3

(0.2)

1

(0.1)

0.33 (0.04–3.19)

0.374

  Feeling hot

3

(0.2)

0

(0.0)

–

0.124

  Dyspepsia

0

(0.0)

4

(0.3)

–

0.125

  Loss of appetite

0

(0.0)

2

(0.2)

–

0.500

  Other

5

(0.4)

7

(0.1)

1.40 (0.44–4.39)

0.774

  1. Data are n (%). Five women with SAEs, and six with drug-related AEs (occurring after administration of the first, correct, treatment) had unintentional treatment crossover and were analysed as per original assignment. P <0.05 marked in bold.
  2. aInclude stillbirths and miscarriages.
  3. bAdmission/prolongation of admission because of SAE.
  4. cSAE reported because of one or more of the following.
  5. dTrauma (2), vaginal haematoma (1), attempted suicide (1), gestational diabetes (1), hyperemesis gravidarum, possible appendicitis (1).
  6. eMajor: spina bifida (1), talipes equinovarus (5), cheilo- and palatoschisis [one with concomitant polydactyly] (2), prune belly syndrome (1), hypospadias (1), trisomy 21 (1), pulmonary atresia (1), multiple abnormalities of unknown cause (2), unilateral hand deformity (1) polydactyly (1), oligodactyly (1); minor: pectus carinatum (1).
  7. fIn the control group 19 women reported a reaction after taking placebo tablets.
  8. gAll due to nausea/vomiting after taking the study medication.
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