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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.