Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00844649 · OUTCOME

Participants With Treatment Emergent Adverse Events (AE)

Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas · Source last updated 2019-11-25

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days

What was measured

A Treatment Emergent Adverse Event (TEAE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: 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: Treated patient population

Groups in this outcome

Albumin-bound Paclitaxel (ABI-007)/Gemcitabine

Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m\^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m\^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest

Gemcitabine

Gemcitabine 1000 mg/m\^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)

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

Analysis denominator · Participants

GroupSource count
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine421
Gemcitabine402

Reported measurements

At least 1 AE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine417Not reportedNot reportedNot reportedNot reported
Gemcitabine395Not reportedNot reportedNot reportedNot reported
≥ 1 Treatment related AE (TEAE)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine403Not reportedNot reportedNot reportedNot reported
Gemcitabine371Not reportedNot reportedNot reportedNot reported
At least 1 Serious Adverse Event (SAE)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine212Not reportedNot reportedNot reportedNot reported
Gemcitabine172Not reportedNot reportedNot reportedNot reported
≥ 1 treatment related SAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine121Not reportedNot reportedNot reportedNot reported
Gemcitabine53Not reportedNot reportedNot reportedNot reported
≥ 1 Grade (GR) 3/4 AE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine370Not reportedNot reportedNot reportedNot reported
Gemcitabine298Not reportedNot reportedNot reportedNot reported
≥ 1 Grade 3 or higher AE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine374Not reportedNot reportedNot reportedNot reported
Gemcitabine303Not reportedNot reportedNot reportedNot reported
≥ 1 AE leading to stopping treatment
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine149Not reportedNot reportedNot reportedNot reported
Gemcitabine95Not reportedNot reportedNot reportedNot reported
≥ 1 AE leading to death
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine18Not reportedNot reportedNot reportedNot reported
Gemcitabine18Not reportedNot reportedNot reportedNot reported
≥ 1 AE leading to dose reduction of ABI-007 or Gem
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine209Not reportedNot reportedNot reportedNot reported
Gemcitabine125Not reportedNot reportedNot reportedNot reported
≥ 1 AE related dose interruption of ABI-007 or Gem
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine11Not reportedNot reportedNot reportedNot reported
Gemcitabine10Not reportedNot reportedNot reportedNot reported
≥ 1 AE related dose delay of ABI-007 or Gem
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Albumin-bound Paclitaxel (ABI-007)/Gemcitabine276Not reportedNot reportedNot reportedNot reported
Gemcitabine192Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        417
      2. group Id
        OG001
        value
        395
    title
    At least 1 AE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        403
      2. group Id
        OG001
        value
        371
    title
    ≥ 1 Treatment related AE (TEAE)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        212
      2. group Id
        OG001
        value
        172
    title
    At least 1 Serious Adverse Event (SAE)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        121
      2. group Id
        OG001
        value
        53
    title
    ≥ 1 treatment related SAE
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        370
      2. group Id
        OG001
        value
        298
    title
    ≥ 1 Grade (GR) 3/4 AE
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        374
      2. group Id
        OG001
        value
        303
    title
    ≥ 1 Grade 3 or higher AE
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        149
      2. group Id
        OG001
        value
        95
    title
    ≥ 1 AE leading to stopping treatment
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        18
    title
    ≥ 1 AE leading to death
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        209
      2. group Id
        OG001
        value
        125
    title
    ≥ 1 AE leading to dose reduction of ABI-007 or Gem
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        10
    title
    ≥ 1 AE related dose interruption of ABI-007 or Gem
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        276
      2. group Id
        OG001
        value
        192
    title
    ≥ 1 AE related dose delay of ABI-007 or Gem
denoms
  1. counts
    1. group Id
      OG000
      value
      421
    2. group Id
      OG001
      value
      402
    units
    Participants
description
A Treatment Emergent Adverse Event (TEAE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: 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
    Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m\^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m\^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
    id
    OG000
    title
    Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
  2. description
    Gemcitabine 1000 mg/m\^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
    id
    OG001
    title
    Gemcitabine
param Type
NUMBER
population Description
Treated patient population
reporting Status
POSTED
time Frame
Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days
title
Participants With Treatment Emergent Adverse Events (AE)
type
OTHER_PRE_SPECIFIED
unit Of Measure
participants

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

Preserved source evidence · Not medical advice