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NCT01013649 · OUTCOME

Number of Participants by Highest Grade Adverse Event Reported (Phase II)

Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery · Source last updated 2026-02-23

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 step 1 randomization (gemcitabine vs. gemcitabine/erlotinib) to death or last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years.

What was measured

Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 which grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

Analysis population: Eligible participants randomized in Step 1 who started protocol treatment and were assessed for adverse events.

Groups in this outcome

Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy)

Patients receive either gemcitabine hydrochloride or \[starting 06-28-2016\] allowable combination chemotherapy per standard of care for 5 months. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.

Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)

\[Closed to accrual 2-28-14.\] Patients receive gemcitabine hydrochloride IV over 30 minutes once a week for 3 weeks then off 1 week and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.

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

Analysis denominator · Participants

GroupSource count
Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy)160
Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)158

Reported measurements

Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy)6Not reportedNot reportedNot reportedNot reported
Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)3Not reportedNot reportedNot reportedNot reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy)20Not reportedNot reportedNot reportedNot reported
Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)24Not reportedNot reportedNot reportedNot reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy)100Not reportedNot reportedNot reportedNot reported
Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)101Not reportedNot reportedNot reportedNot reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy)32Not reportedNot reportedNot reportedNot reported
Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)27Not reportedNot reportedNot reportedNot reported
Grade 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy)2Not reportedNot reportedNot reportedNot reported
Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        3
    title
    Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        24
    title
    Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        100
      2. group Id
        OG001
        value
        101
    title
    Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        27
    title
    Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
    title
    Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      160
    2. group Id
      OG001
      value
      158
    units
    Participants
description
Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 which grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
groups
  1. description
    Patients receive either gemcitabine hydrochloride or \[starting 06-28-2016\] allowable combination chemotherapy per standard of care for 5 months. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
    id
    OG000
    title
    Arm I (Gemcitabine Hydrochloride or Combination Chemotherapy)
  2. description
    \[Closed to accrual 2-28-14.\] Patients receive gemcitabine hydrochloride IV over 30 minutes once a week for 3 weeks then off 1 week and erlotinib hydrochloride PO once daily on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.
    id
    OG001
    title
    Arm II (Gemcitabine Hydrochloride, Erlotinib Hydrochloride)
param Type
COUNT_OF_PARTICIPANTS
population Description
Eligible participants randomized in Step 1 who started protocol treatment and were assessed for adverse events.
reporting Status
POSTED
time Frame
From step 1 randomization (gemcitabine vs. gemcitabine/erlotinib) to death or last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years.
title
Number of Participants by Highest Grade Adverse Event Reported (Phase II)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice