Endpoint
Serious adverse event incidence
CAT:outcome/serious-adverse-event-incidencereported in event rate
Method
Proportion of participants experiencing at least one event meeting the trial protocol regulatory seriousness criteria (death, life-threatening event, inpatient hospitalisation or its prolongation, persistent or significant disability, congenital anomaly, or an event requiring intervention to prevent one of these), pooled as a risk ratio.
The method is part of the endpoint identity. Studies measuring the same quantity by a different method are held as separate endpoints.
Notes
Distinct from any-adverse-event incidence and from gastrointestinal adverse event incidence. Seriousness here is a regulatory classification, not a severity impression, so the base rate is one to two orders of magnitude lower and typical trials are grossly underpowered for it. A null result here means almost nothing about tolerability, while a null all-cause adverse event result does; conflating them lets an underpowered null be read as a safety endorsement. Excludes withdrawal-due-to-adverse-event counts, which capture tolerability rather than seriousness.
Findings
1 finding from 1 compound, strongest first.
melatonin — no detected effect on
LikelyGrade B, Likely. Human evidence, limited replication or design limits.FindingNull result“In terms of safety, no serious adverse events were reported with either melatonin or placebo.”
Quoted verbatim from Effect of melatonin versus placebo for the prevention of delirium among medically hospitalised older patients: a double-blinded randomised controlled trial (project RESTORE).. - Study
- RCT
- Duration
- 5 days
- Dose
- 5 mg or 8 mg oral melatonin nightly for up to 5 days (arms pooled)
- Population
- medically hospitalised patients aged 65 years and over; safety endpoint, ITT