Accepted answer
The SURMOUNT-2 placebo arm is the only thing that makes its treatment arm interpretable, and it is the row nobody quotes. Symptoms reported under placebo in these programmes are not rare, because the population is being asked about them weekly and would have had some of them regardless. The attributable figure is the treated rate minus the placebo rate, and that difference is routinely a fraction of the headline. Two cautions on the subtraction: the arms must have been assessed the same way, and a discontinuation for an event removes that participant from later time points in both arms, which flatters whichever arm loses more people.
The part that matters: a trial establishes what happened to a defined group under a defined protocol. Extending it beyond that group is inference, and inference is allowed as long as it is labelled.
Non-inferiority and superiority designs are not interchangeable. A non-inferiority result says the new agent is not meaningfully worse against a pre-specified margin — it does not say it is as good, and it certainly does not say it is better.
Intention-to-treat and per-protocol analyses answer different questions. ITT asks what happens if you offer the treatment; per-protocol asks what happens if it is taken as directed. The gap between the two is a measure of how tolerable the protocol was.
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.
The short version: check the endpoint, check the comparator, check who was excluded, then look at the number.
6Same experience here, different supplier. – tobias_reint 25 days ago 7Is the open-label extension included in that figure, or just the randomised phase? – Dr_Aoife_Brennan 2 months ago add a comment