Gastrointestinal adverse events with incretin receptor agonists — amendment log
Every change made since protocol registration, with its date and reason.
§5Amendment log
Every change made to this review after protocol registration is recorded below with its date and its reason. A change that is not in this log did not happen. The Institute publishes the log in full, including changes that did not alter a conclusion, because a reader cannot judge which changes matter unless all of them are visible.
§5.1Amendment log
Table 9. Amendments to this review since protocol registration.
| Date | Version | Amendment | Record |
|---|---|---|---|
| 17 Mar 2025 | 0.1 | Protocol registered | The review protocol was registered with the Institute’s secretariat before the search was executed. No change to the review question was made after registration. |
| 02 Aug 2025 | 2.1 | Certainty rating revised | The certainty rating for one outcome was revised following the addition of a contributing study. The rationale is recorded in the certainty assessment section. |
| 08 Dec 2025 | 2.2 | Analysis method changed | The pooling method was changed from a fixed-effect to a random-effects model following observation of between-study heterogeneity exceeding the pre-specified threshold. |
| 24 Mar 2026 | 2.3 | Comment-period disposition applied | Amendments arising from the disposition of a public comment period were applied. Each amendment is traceable to a numbered submission. |
| 20 Jun 2026 | 2.0 | Outcome added | An additional outcome was added at the request of a public comment-period respondent. The addition is recorded here because it was made after protocol registration and is therefore post hoc. |
| Current version 2.0, ratified in the 2025 Q2 assessment cycle. | |||
§5.2Clinical study report requests
Table 10. Clinical study reports requested for the contributing trials, and the outcome of each request. Refusals are recorded because a review that does not record them presents the sponsor's disclosure decision as the Institute's own.
| Trial | Requested | Outcome |
|---|---|---|
| ACHIEVE-1 | 11 Mar 2025 | Partially supplied |
| ACHIEVE-2 | 09 Jan 2025 | Redirected to a data-access portal |
| ATTAIN-1 | 25 Jan 2025 | Refused |
| ATTAIN-2 | 25 Feb 2025 | No response |
| STRIDE | 10 Feb 2025 | No response |
| SURMOUNT-5 | 14 Jan 2025 | No response |
| SURMOUNT-KOA | 12 Mar 2025 | No response |
| SURPASS-CVOT | 02 Mar 2025 | Refused |
§5.3Superseded versions
Superseded versions of this review remain published at a stable address, are marked as superseded, and link forward to the current version. The current version links back to each of them. That practice was adopted following a submission that a document cited in the literature must remain retrievable in the form in which it was cited; the reasoning is published on the corrections policy disposition page.
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF. Once-weekly semaglutide in adults with overweight or obesity. New England Journal of Medicine 2021;384(11):989–1002. doi:10.1056/NEJMoa2032183 · PMID 33567185
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.