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NCT04165031 · OUTCOME

Phase 1: Number or Participants With Dose Limiting Toxicities (DLTs)

A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation · Source last updated 2021-11-24

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
Cycle 1 (21 Day Cycle)

What was measured

DLT is defined as an event that is clinically significant and not clearly related to disease progression or intercurrent illness that occurred within the DLT observation period of the Cycle 1 timeframe.

Analysis population: All participants who received at least one dose of study drug and had a dose limiting toxicity.

Groups in this outcome

LY3499446 Phase 1 Cohort A1 (High Dose)

Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles.

LY3499446 Phase 1 Cohort AO (Mid Dose)

Participant received mid dose LY3499446 as oral monotherapy once QOD in 21-day cycles.

LY3499446 Phase 1 Cohort A-2 (Low Dose)

Participants received low dose LY3499446 as oral monotherapy once QD in 21-day cycles.

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

Analysis denominator · Participants

GroupSource count
LY3499446 Phase 1 Cohort A1 (High Dose)2
LY3499446 Phase 1 Cohort AO (Mid Dose)1
LY3499446 Phase 1 Cohort A-2 (Low Dose)2

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LY3499446 Phase 1 Cohort A1 (High Dose)2Not reportedNot reportedNot reportedNot reported
LY3499446 Phase 1 Cohort AO (Mid Dose)1Not reportedNot reportedNot reportedNot reported
LY3499446 Phase 1 Cohort A-2 (Low Dose)1Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      2
    units
    Participants
description
DLT is defined as an event that is clinically significant and not clearly related to disease progression or intercurrent illness that occurred within the DLT observation period of the Cycle 1 timeframe.
groups
  1. description
    Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles.
    id
    OG000
    title
    LY3499446 Phase 1 Cohort A1 (High Dose)
  2. description
    Participant received mid dose LY3499446 as oral monotherapy once QOD in 21-day cycles.
    id
    OG001
    title
    LY3499446 Phase 1 Cohort AO (Mid Dose)
  3. description
    Participants received low dose LY3499446 as oral monotherapy once QD in 21-day cycles.
    id
    OG002
    title
    LY3499446 Phase 1 Cohort A-2 (Low Dose)
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants who received at least one dose of study drug and had a dose limiting toxicity.
reporting Status
POSTED
time Frame
Cycle 1 (21 Day Cycle)
title
Phase 1: Number or Participants With Dose Limiting Toxicities (DLTs)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice