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 |