Accepted answer
Only what the 14 mg arm reported, and the denominator is that arm rather than the trial. Adverse-event tables are published per arm, so the 14 mg incidence of reflux has its own numerator and its own denominator, and pooling it with the other arms produces a figure that describes nobody. Two further deductions before you use it. Subtract the placebo arm — reflux occurs in people who received nothing, and the difference is the part attributable to the drug. And check whether SOUL counted events or counted participants: one participant with six episodes is one row in a participant count and six in an event count, and the two get quoted interchangeably. Nothing here is medical advice.
The trial answers a narrower question than the headline suggests, and the narrowing is where the useful information is.
Placebo arms in this class are not nothing. Lifestyle-intervention placebo arms in the major obesity trials commonly lose two to three per cent of body weight, so an active-arm figure quoted without its comparator overstates the drug effect by roughly that much.
A composite endpoint is only as informative as its least serious component. Where a cardiovascular composite combines death, infarction and stroke, ask which component moved, because they are not interchangeable outcomes.
Registry entries at ClinicalTrials.gov carry the pre-specified primary endpoint with a timestamp, which is the cheapest available check on whether an endpoint was changed after the data were seen.
I am not a clinician and this is not medical advice; it is a reading of a published protocol.
If a claim cannot be traced to a named trial with a named endpoint, treat it as a claim rather than as evidence.
Good answer, but the confidence interval in the cited trial is wider than implied. – fresh_bac 8 months ago 2Which population was that figure from? It moves a lot between the trials. – rhian_prydderch 9 months ago add a comment