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Table 5 Study gas discontinuation 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
Temporary discontinuation 7/88 (8.0) 3/92 (3.3) 0.21
 Methaemoglobinaemia 5/88 (5.7) 0 0.026
 Elevated inspired NO2 concentration 0 0
 Persistent hypoxaemia 0 0
 Evolving respiratory distress 0 0
 Unexplained tachycardia 1/88 (1.1) 0 0.49
 Unexplained hypotension 0 0
 Subject or guardian’s discretion 0 0
 Investigator’s discretion 1/88 (1.1) 3/92 (3.3) 0.62
Permanent discontinuation 12/88 (14) 10/92 (11) 0.57
 Refractory methaemoglobinaemia 0 0
 Haemoptysis 0 0
 Acute kidney injury 7/88 (8.0) 3/92 (3.3) 0.21
 Adverse event that repeats upon re-challenge 0 0
 Subject or guardian’s discretiona 4/88 (4.5) 4/92 (4.3) 1.0
 Investigator’s discretiona 1/88 (1.1) 2/92 (2.2) 1.0
 Death (48 h) 6/88 (6.8) 8/92 (8.8) 0.62
 Death (Day 14) 7/88 (8.0) 9/92 (9.9) 0.65
  1. aSome children who regained consciousness before 72 h had elapsed on study gas did not tolerate wearing a non-rebreather mask. The study gas was discontinued early at the investigator’s or the child/parent’s discretion in these cases