Table 4.
Safety endpoints during treatment.
| Event | NO | Placebo | P value | ||
|---|---|---|---|---|---|
| n/39a | % | n/39a | % | ||
| Unblinding | 0 | 0% | 1 | 3% | 1.000 |
| Escalated to thrombolysis | 0 | 0% | 3 | 8% | 0.240 |
| Escalated to thrombectomy | 0 | 0% | 1 | 3% | 1.000 |
| Bleedingb | 0 | 0% | 1 | 3% | 1.000 |
| Hypotension | 2 | 5% | 1 | 3% | 1.000 |
| Respiratory distress requiring intervention | 1 | 3% | 1 | 3% | 1.000 |
| METH018 – Supportive Rx: continued O2 support | |||||
| METH027 – Supportive Rx: Cpap continuation at night. | |||||
| Hypoxemia requiring intervention | 3 | 8% | 1 | 3% | 0.615 |
| ESKE002 – Supportive Rx: O2 evaluation for home oxygen. Increase in NC flow from 4L (rest) - 6L (exertion) of O2. | |||||
| ESKE008 - Supportive Rx: O2 evaluation for home oxygen. Increase in NC flow from 1L (rest) - 2L (exertion) of O2. | |||||
| METH019 - Supportive Rx: O2 evaluation for home oxygen & discharged with home O2. | |||||
| METH028 – Supportive Rx: Bipap use at night for untreated sleep apnea | |||||
| Arrhythmia requiring intervention | 2 | 5% | 1 | 3% | 1.000 |
| ESKE003 – Supportive Rx: Patient restarted on home medication, Diltiazem 30 mg PO QID, due to reported A-fib with RVR with HR = 124. | |||||
| METH014 – Supportive Rx: metoprolol started | |||||
| METH049 – Supportive Rx: Amniodarone increased from 200 mg to 600 mg PO | |||||
| Death | 0 | 0% | 0 | 0% | 1.000 |
| Other adverse event requiring medication or supportive carec | 12 | 31% | 10 | 26% | 0.802 |
a
N = 39 used in each group for denominator despite voluntary withdrawal of one subject in each group prior to completion of the 24 h protocol because 39 in each group receive NO for some time period.
b
Vaginal bleeding without need for transfusion or procedural intervention.
c
Zero instances of vasopressor use, cardiopulmonary resuscitation, death bronchospasm, neurological deterioration, gastrointestinal distress or methemoglobi-nemia > 10% for 1 h during the 24 h treatment period.