NCT01804140 · ADVERSE EVENTS

Adverse events

A Screening Study to Detect BRAF V600 Mutation-Positive Patients For Enrollment Into Clinical Research Studies of Zelboraf (Vemurafenib) · Source last updated 2016-11-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: All adverse events that occurred up to 28 days after the biopsy was performed or those adverse events that the physician considered to have causal relationship to the biopsy performed were recorded.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Participants With Confirmed Solid Tumors or Multiple Myeloma Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.	0 / 548	0 / 548	Not reported / Not reported

Group identifiers: EG000: Participants With Confirmed Solid Tumors or Multiple Myeloma

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Complete source fields

event Groups

description
Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
id
EG000
other Num Affected
0
other Num At Risk
548
serious Num Affected
0
serious Num At Risk
548
title
Participants With Confirmed Solid Tumors or Multiple Myeloma

frequency Threshold

time Frame

All adverse events that occurred up to 28 days after the biopsy was performed or those adverse events that the physician considered to have causal relationship to the biopsy performed were recorded.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice