From: Nonadherence to treatment protocol in published randomised controlled trials: a review
 | Number (%a) | |
---|---|---|
Harms analysis population specifically defined in methods | 26 (38) | |
Defined harms analysis population | Based on actual treatment received (that is, including all patients who had received at least one administration of treatment) | 18 |
 | Intention to treat | 5 |
 | All who started allocated treatment | 2 |
 | All who completed allocated treatment | 1 |
Harms analysis population not specifically defined in methods | 43 (62) | |
Inferred harms analysis population | Stated ‘safety population’ without further definition | 1 |
 | Apparently analysed as per efficacy outcomes | 33 |
 | Intention to treat definition | 31 |
 | Per protocol definition | 2 |
 | No details given of harms or benefit analysis population | 9 |