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NCT02186847 · OUTCOME

Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events

Chemotherapy and Radiation Therapy With or Without Metformin Hydrochloride in Treating Patients With Stage III Non-small Cell Lung Cancer · Source last updated 2026-07-13

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From start of treatment to last follow-up. Maximum follow-up at time of analysis was 47.2 months.

What was measured

Adverse events (AE) were 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, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event. "Treatment-related" is defined definitely, probably, or possibly related to treatment.

Analysis population: Eligible participants who started protocol treatment

Groups in this outcome

Chemoradiation

60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin

Metformin + Chemoradiation

Metformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin

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

Analysis denominator · Participants

GroupSource count
Chemoradiation76
Metformin + Chemoradiation82

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Chemoradiation67.1Not reported55.477.5Not reported
Metformin + Chemoradiation63.4Not reported52.173.8Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.47
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.80
    estimate Comment
    Reference level = Chemoradiation
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6266
    param Type
    Odds Ratio (OR)
    param Value
    0.92
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. ci Lower Limit
    0.47
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.80
    estimate Comment
    Reference level = Chemoradiation
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6266
    param Type
    Odds Ratio (OR)
    param Value
    0.92
    statistical Comment
    Two-sided significance level = 0.05
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        55.4
        upper Limit
        77.5
        value
        67.1
      2. group Id
        OG001
        lower Limit
        52.1
        upper Limit
        73.8
        value
        63.4
denoms
  1. counts
    1. group Id
      OG000
      value
      76
    2. group Id
      OG001
      value
      82
    units
    Participants
description
Adverse events (AE) were 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, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event. "Treatment-related" is defined definitely, probably, or possibly related to treatment.
dispersion Type
95% Confidence Interval
groups
  1. description
    60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
    id
    OG000
    title
    Chemoradiation
  2. description
    Metformin plus 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
    id
    OG001
    title
    Metformin + Chemoradiation
param Type
NUMBER
population Description
Eligible participants who started protocol treatment
reporting Status
POSTED
time Frame
From start of treatment to last follow-up. Maximum follow-up at time of analysis was 47.2 months.
title
Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice