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NCT01822496 · OUTCOME

Number of Patients With Grade 3-5 Adverse Events

Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer · Source last updated 2019-08-05

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
From randomization to study termination. Maximum follow-up was 39.0 months

What was measured

Adverse events (AE) are graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

Analysis population: Eligible patients who started study treatment

Groups in this outcome

EGFR: Erlotinib

Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.

EGFR: No Erlotinib

Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.

ALK: Crizotinib

Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.

ALK: No Crizotinib

Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.

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

Analysis denominator · Participants

GroupSource count
EGFR: Erlotinib14
EGFR: No Erlotinib20
ALK: Crizotinib9
ALK: No Crizotinib7

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EGFR: Erlotinib0Not reportedNot reportedNot reportedNot reported
EGFR: No Erlotinib0Not reportedNot reportedNot reportedNot reported
ALK: Crizotinib0Not reportedNot reportedNot reportedNot reported
ALK: No Crizotinib0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      20
    3. group Id
      OG002
      value
      9
    4. group Id
      OG003
      value
      7
    units
    Participants
description
Adverse events (AE) are graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
groups
  1. description
    Induction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
    id
    OG000
    title
    EGFR: Erlotinib
  2. description
    Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
    id
    OG001
    title
    EGFR: No Erlotinib
  3. description
    Induction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
    id
    OG002
    title
    ALK: Crizotinib
  4. description
    Chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
    id
    OG003
    title
    ALK: No Crizotinib
param Type
COUNT_OF_PARTICIPANTS
population Description
Eligible patients who started study treatment
reporting Status
POSTED
time Frame
From randomization to study termination. Maximum follow-up was 39.0 months
title
Number of Patients With Grade 3-5 Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice