NCT04607421 · OUTCOME

SLI: Number of Participants With Dose Modification of Any Study Intervention Due to AEs

A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer · Source last updated 2026-06-11

This outcome was registered, but no numerical results were posted in the captured record.

Measure: Not reported
Unit: Not reported
Interval / dispersion: Not reported
Time frame: Through end of the study

What was measured

An AE was any untoward medical occurrence in clinical study participant temporally associated with use of study intervention, whether or not considered related to study intervention. Dose interruption: for encorafenib = 0 mg dose administered for \>=1 days; for cetuximab, oxaliplatin, leucovorin, fluorouracil, irinotecan: \>20 days between successive start dates with non-zero actual doses. Dose reduction: decrease in dose of at least 10%, from the protocol-planned dose and a decrease from the previous non-zero dose; for encorafenib to qualify as a dose reduction, it should have lasted for \>=2 days. Dose modifications included both dose interruptions and reduction.

Groups in this outcome

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields

anticipated Posting Date: 2027-12
denom Units Selected: Participants
description: An AE was any untoward medical occurrence in clinical study participant temporally associated with use of study intervention, whether or not considered related to study intervention. Dose interruption: for encorafenib = 0 mg dose administered for \>=1 days; for cetuximab, oxaliplatin, leucovorin, fluorouracil, irinotecan: \>20 days between successive start dates with non-zero actual doses. Dose reduction: decrease in dose of at least 10%, from the protocol-planned dose and a decrease from the previous non-zero dose; for encorafenib to qualify as a dose reduction, it should have lasted for \>=2 days. Dose modifications included both dose interruptions and reduction.
reporting Status: NOT_POSTED
time Frame: Through end of the study
title: SLI: Number of Participants With Dose Modification of Any Study Intervention Due to AEs
type: SECONDARY

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Preserved source evidence · Not medical advice