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Table 7 Adverse events in the study

From: Oral prednisolone for acute otitis media in children: a pilot, pragmatic, randomised, open-label, controlled study (OPAL study)

Adverse events Prednisolone group (n = 31) Control (n = 31)
No ptsa Day 1–3 Day 4–7 Day 8–14 No ptsa Day 1–3 Day 4–7 Day 8–14
Increased appetite 18 11 15 17 17 9 10 7
Increased urine volume 11 8 9 7 14 12 7 4
Weight gain 13 5 6 6 11 4 4 10
Gastritis 2 3 2 0 4 2 0 0
Nausea 6 4 1 0 7 5 4 1
Vomiting 5 3 0 0 3 3 1 1
Diarrhoea 2 3 1 1 4 1 0 0
Drowsiness 23 14 9 6 13 16 10 5
Anxiety 4 3 3 3 6 3 1 1
Headache 4 1 0 1 6 7 2 3
Skin rash 3 0 1 0 0 2 0 0
Candidiasis 3 2 1 0 1 1 0 0
Dry mouth 7 5 4 0 6 6 3 1
Sleep disturbance 17 5 5 3 10 9 1 0
Others 1 0b 1 0 0 0 0 0
Serious adverse effects 0 0 0 0 0 0 0 0
  1. aTotal number of patients having the adverse event during the first 2 weeks
  2. bPatient was detected to have anemia at day 6 (no baseline Hb count was identified) at the primary care centre and was referred to paediatrician
  3. Pts patients