Draft monograph: Maridebart cafraglutide — disposition

§3Disposition and amendments

§3.1Disposition table

Table 1. Every submission with its disposition. Each row links to the submission in full.

§3.2Summary by disposition

Table 2. Counts by disposition, with the meaning of each.

§3.3Resulting amendments

1. Local reactions are omitted from the adverse-event table because the trials reported them separately — arising from DRAFT-MARIDEBART-C/001. Local reactions are now carried in the adverse-event table wherever the source trials report them, footnoted with the convention each trial used.
2. The route of administration studied is not the route in which the compound is supplied — arising from DRAFT-MARIDEBART-C/002. The assessed-outcome table now carries the studied route in every row, and a standing note appears wherever the supplied presentation differs from it.
3. Quantitative claims are reproduced without the method that produced them — arising from DRAFT-MARIDEBART-C/003. Every quantitative claim now carries the determination that produced it at the point of use, and figures obtained by non-comparable methods are no longer presented in the same row or sentence.
4. Open-label extension data are presented alongside randomised data without distinction — arising from DRAFT-MARIDEBART-C/004. Extension data now appear in a separate table headed as uncontrolled follow-up, with a standing note on differential withdrawal.
5. Registered trials that never reported are absent from the monograph — arising from DRAFT-MARIDEBART-C/005. The trial list now includes every registered trial the Institute identified, with its reporting status stated, and the monograph reports the proportion of registered trials for which no result has been posted or published.
6. The cardiovascular result is reported without the population that generated it — arising from DRAFT-MARIDEBART-C/006. Absolute event rates in both arms are now printed beside every relative estimate in this class, and the enrolment criterion is repeated in the outcome row rather than only in the population section.
7. The indication table mixes approved indications with uses for which the compound is merely supplied — arising from DRAFT-MARIDEBART-C/007. The indication table now carries a status column with three values, approved, under investigation and supplied without trial evidence, and the value is stated for every row. Rows in the third category also state that no certainty rating is assigned because…
8. The monograph does not tell a reader that a stated mass may be substantially counter-ion and water — arising from DRAFT-MARIDEBART-C/008. The monograph now states, at the point where vial contents are first mentioned, that a mass figure is uninterpretable unless it states whether it is peptide content or total solids, and cross-references the content standard in the analytical series.
9. The absence of a rare harm in the trial set is presented as reassurance — arising from DRAFT-MARIDEBART-C/009. Wherever the monograph reports that an event was not observed, it now states the total exposure and the frequency the contributing trials could have detected, so that the absence is read as the limit of the evidence rather than as a finding.

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.

1. International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute

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