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NCT02797964 · OUTCOME

Number of Subjects With Adverse Events as Assessed by CTCAE 4.03

A Phase 1/2 Trial of SRA737 in Subjects With Advanced Cancer · Source last updated 2023-06-18

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 30 days after last dose of SRA737

What was measured

Treatment-emergent adverse events (TEAEs) were reported until the safety Follow up (SFU) visit, 30 days after the last dose of SRA737 or prior to the initiation of a new anticancer treatment, whichever came first.

Analysis population: As specified in the Statistical Analysis Plan, the frequency of each AE was evaluated in the overall Safety Evaluable Population rather than by tumor type subgroups with the intention of displaying the overall safety profile of SRA737 in advanced solid tumors. The Safety Evaluable Population includes all enrolled subjects who receive at least 1 dose of SRA737.

Groups in this outcome

Safety Evaluable Population

The Safety Evaluable Population includes all enrolled subjects who receive at least 1 dose of SRA737.

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

Analysis denominator · Participants

GroupSource count
Safety Evaluable Population107

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Evaluable Population106Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        106
denoms
  1. counts
    1. group Id
      OG000
      value
      107
    units
    Participants
description
Treatment-emergent adverse events (TEAEs) were reported until the safety Follow up (SFU) visit, 30 days after the last dose of SRA737 or prior to the initiation of a new anticancer treatment, whichever came first.
groups
  1. description
    The Safety Evaluable Population includes all enrolled subjects who receive at least 1 dose of SRA737.
    id
    OG000
    title
    Safety Evaluable Population
param Type
COUNT_OF_PARTICIPANTS
population Description
As specified in the Statistical Analysis Plan, the frequency of each AE was evaluated in the overall Safety Evaluable Population rather than by tumor type subgroups with the intention of displaying the overall safety profile of SRA737 in advanced solid tumors. The Safety Evaluable Population includes all enrolled subjects who receive at least 1 dose of SRA737.
reporting Status
POSTED
time Frame
Up to 30 days after last dose of SRA737
title
Number of Subjects With Adverse Events as Assessed by CTCAE 4.03
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice