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

Malaria Journal

Table 4 Adverse events according to treatment group

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 1^a	8/88 (9.1)	8/92 (8.8)	1.0
Grade 2^a	11/88 (13)	10/92 (11)	0.82
Grade 3^a	3/88 (3.4)	3/92 (3.3)	1.0
Grade 4^a	8/88 (9.1)	3/92 (3.3)	0.13
Acute kidney injury^b	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

^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]
^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]

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