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NCT01876511 · OUTCOME

Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity

Study of MK-3475 in Patients With Microsatellite Unstable (MSI) Tumors (Cohorts A, B and C) · Source last updated 2020-02-06

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
28 months

What was measured

When calculating the incidence of AEs, each adverse event (AE) (as defined by NCI CTCAE v4.03) will be counted only once for a given subject.

Groups in this outcome

Cohort A: MSI Positive Colorectal Cancer

MK-3475: MK-3475 10 mg/kg every 14 days

Cohort B: MSI Negative Colorectal Cancer

MK-3475: MK-3475 10 mg/kg every 14 days

Cohort C: MSI Positive Non-Colorectal Cancer

MK-3475: MK-3475 10 mg/kg every 14 days

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

Analysis denominator · Participants

GroupSource count
Cohort A: MSI Positive Colorectal Cancer41
Cohort B: MSI Negative Colorectal Cancer25
Cohort C: MSI Positive Non-Colorectal Cancer47

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: MSI Positive Colorectal Cancer12Not reportedNot reportedNot reportedNot reported
Cohort B: MSI Negative Colorectal Cancer0Not reportedNot reportedNot reportedNot reported
Cohort C: MSI Positive Non-Colorectal Cancer13Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        13
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    2. group Id
      OG001
      value
      25
    3. group Id
      OG002
      value
      47
    units
    Participants
description
When calculating the incidence of AEs, each adverse event (AE) (as defined by NCI CTCAE v4.03) will be counted only once for a given subject.
groups
  1. description
    MK-3475: MK-3475 10 mg/kg every 14 days
    id
    OG000
    title
    Cohort A: MSI Positive Colorectal Cancer
  2. description
    MK-3475: MK-3475 10 mg/kg every 14 days
    id
    OG001
    title
    Cohort B: MSI Negative Colorectal Cancer
  3. description
    MK-3475: MK-3475 10 mg/kg every 14 days
    id
    OG002
    title
    Cohort C: MSI Positive Non-Colorectal Cancer
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
28 months
title
Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice