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NCT01139775 · OUTCOME

Deaths

A Study in Non Small Cell Lung Cancer · Source last updated 2018-05-18

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
Randomization through 12 months after the last participant was randomized

What was measured

Deaths that occurred during the study are presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Analysis population: All enrolled participants.

Groups in this outcome

Phase 1: Pemetrexed + Cisplatin + LY2603618

Cycles 1-2 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 130 to 275 mg After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.

Phase 2: Pemetrexed + Cisplatin + LY2603618

Cycles 1-4 (21-day cycle): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.

Phase 2: Pemetrexed + Cisplatin

Cycles 1-4 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Day 1: pemetrexed 500 mg/m\^2 Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour.

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

Analysis denominator · Participants

GroupSource count
Phase 1: Pemetrexed + Cisplatin + LY260361814
Phase 2: Pemetrexed + Cisplatin + LY260361839
Phase 2: Pemetrexed + Cisplatin23

Reported measurements

Total deaths
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Pemetrexed + Cisplatin + LY26036180Not reportedNot reportedNot reportedNot reported
Phase 2: Pemetrexed + Cisplatin + LY260361821Not reportedNot reportedNot reportedNot reported
Phase 2: Pemetrexed + Cisplatin15Not reportedNot reportedNot reportedNot reported
Deaths while on treatment
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Pemetrexed + Cisplatin + LY26036180Not reportedNot reportedNot reportedNot reported
Phase 2: Pemetrexed + Cisplatin + LY26036183Not reportedNot reportedNot reportedNot reported
Phase 2: Pemetrexed + Cisplatin1Not reportedNot reportedNot reportedNot reported
Death within 30 days of last dose of study drug
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Pemetrexed + Cisplatin + LY26036180Not reportedNot reportedNot reportedNot reported
Phase 2: Pemetrexed + Cisplatin + LY26036181Not reportedNot reportedNot reportedNot reported
Phase 2: Pemetrexed + Cisplatin0Not reportedNot reportedNot reportedNot reported
Deaths during follow-up period
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Pemetrexed + Cisplatin + LY26036180Not reportedNot reportedNot reportedNot reported
Phase 2: Pemetrexed + Cisplatin + LY260361817Not reportedNot reportedNot reportedNot reported
Phase 2: Pemetrexed + Cisplatin14Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        21
      3. group Id
        OG002
        value
        15
    title
    Total deaths
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        1
    title
    Deaths while on treatment
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Death within 30 days of last dose of study drug
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        17
      3. group Id
        OG002
        value
        14
    title
    Deaths during follow-up period
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      39
    3. group Id
      OG002
      value
      23
    units
    Participants
description
Deaths that occurred during the study are presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
groups
  1. description
    Cycles 1-2 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 130 to 275 mg After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
    id
    OG000
    title
    Phase 1: Pemetrexed + Cisplatin + LY2603618
  2. description
    Cycles 1-4 (21-day cycle): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
    id
    OG001
    title
    Phase 2: Pemetrexed + Cisplatin + LY2603618
  3. description
    Cycles 1-4 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Day 1: pemetrexed 500 mg/m\^2 Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour.
    id
    OG002
    title
    Phase 2: Pemetrexed + Cisplatin
param Type
COUNT_OF_PARTICIPANTS
population Description
All enrolled participants.
reporting Status
POSTED
time Frame
Randomization through 12 months after the last participant was randomized
title
Deaths
type
OTHER_PRE_SPECIFIED
unit Of Measure
Participants

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Preserved source evidence · Not medical advice