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Table 4 Adverse events according to treatment group

From: Inhaled nitric oxide as adjunctive therapy for severe malaria: a randomized controlled trial

Adverse event iNO (n/N, %) Placebo (n/N, %) p value
Hyperglycaemia (> 6.8 mmol/L) 34/88 (39) 29/92 (32) 0.32
Hypoglycaemia (< 3 mmol/L) 5/88 (5.7) 2/92 (2.2) 0.27
Elevated creatinine 30/88 (34) 24/92 (26) 0.26
 Grade 1a 8/88 (9.1) 8/92 (8.8) 1.0
 Grade 2a 11/88 (13) 10/92 (11) 0.82
 Grade 3a 3/88 (3.4) 3/92 (3.3) 1.0
 Grade 4a 8/88 (9.1) 3/92 (3.3) 0.13
 Acute kidney injuryb 7/88 (8.0) 3/92 (3.3) 0.21
Hypotension 0 0
Anaemia 9/88 (10) 6/92 (6.6) 0.38
IV Site oedema or induration 17/88 (19) 10/92 (11) 0.12
Peri-orbital oedema 17/88 (19) 4/92 (4.4) 0.002
Vomiting 4/88 (4.5) 4/92 (4.4) 1.0
Conjunctivitis 1/88 (1.1) 1/92 (1.1) 1.0
Diarrhoea 5/88 (5.7) 4/92 (4.4) 0.74
Fever 4/88 (4.5) 5/92 (5.4) 1.0
Cough 5/88 (5.7) 5/92 (5.4) 0.94
Stridor 0 2/92 (2.2) 0.50
Cellulitis 4/88 (4.5) 1/92 (1.1) 0.20
Headache 0 1/92 (1.1) 1.0
Jaundice 1/88 (1.1) 3/92 (3.3) 0.62
Other 14/88 (16) 7/92 (7.7) 0.11
Withdrawal of study gas 19/88 (22) 13/92 (14) 0.13
  1. aElevated creatinine was defined as follows: For children age 1 to <2 years old, grade 1: 0.6–0.89 × upper limit of normal (ULN); grade 2: 0.9–1.19 × ULN; grade 3: 1.2–1.5 × ULN, grade 4: >1.5 × ULN. For children 2–10 years old, grade 1: 0.7–1.0 × ULN; grade 2: 1.1–1.6 × ULN; grade 3: 1.7–2.0 × ULN, grade 4: >2.0 × ULN [27]
  2. bAcute kidney injury was defined as follows: Serum creatinine >1.5 × ULN (children age 1–2) or >2.0 × ULN (age 2–10) AND an abrupt (within 48 h) reduction in kidney function: (1) an absolute increase in serum creatinine of ≥26.4 μmol/l; or (2) a percentage increase in serum creatinine of ≥50 % [32]