NCT04607421 · OUTCOME

Phase 3: Number of Participants According to Categorization of Vital Signs Data

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

The criteria for vital signs included: Systolic blood pressure (mmHg): value \<= 90 mmHg and decrease from baseline \>= 20 mmHg, and value \>= 160 mmHg and increase from baseline \>= 20 mmHg. Diastolic blood pressure (mmHg): value \<= 50 mmHg and decrease from baseline \>= 15 mmHg, and value \>= 100 mmHg and increase from baseline \>= 15 mmHg. Pulse rate (bpm): value \<= 50 bpm and decrease from baseline \>= 15 bpm, and value \>= 120 bpm and increase from baseline \>= 15 bpm. Weight (kg): change \>= 20 % decrease from baseline, and change \>=10% increase from baseline. Temperature (degree Celsius): value \<=36 degree Celsius, and value \>=37.5 degree Celsius. Only those criteria in which at least 1 participant in any of the reporting arm had any vital signs data are reported in this outcome measure.

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: The criteria for vital signs included: Systolic blood pressure (mmHg): value \<= 90 mmHg and decrease from baseline \>= 20 mmHg, and value \>= 160 mmHg and increase from baseline \>= 20 mmHg. Diastolic blood pressure (mmHg): value \<= 50 mmHg and decrease from baseline \>= 15 mmHg, and value \>= 100 mmHg and increase from baseline \>= 15 mmHg. Pulse rate (bpm): value \<= 50 bpm and decrease from baseline \>= 15 bpm, and value \>= 120 bpm and increase from baseline \>= 15 bpm. Weight (kg): change \>= 20 % decrease from baseline, and change \>=10% increase from baseline. Temperature (degree Celsius): value \<=36 degree Celsius, and value \>=37.5 degree Celsius. Only those criteria in which at least 1 participant in any of the reporting arm had any vital signs data are reported in this outcome measure.
reporting Status: NOT_POSTED
time Frame: Through end of the study
title: Phase 3: Number of Participants According to Categorization of Vital Signs Data
type: SECONDARY

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Preserved source evidence · Not medical advice