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NCT02101788 · OUTCOME

Incidence of Adverse Events (AEs)

Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer · Source last updated 2026-08-04

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
During treatment period and up to 100 days after stopping the study treatment

What was measured

Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy. Excludes AEs observed among control patients treated with trametinib after crossover.Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the AE endpoint definition.

Analysis population: Treated with randomized therapy

Groups in this outcome

Arm A - Control Arm

Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days

Arm B - Experimental Arm

Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days

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 A - Control Arm127
Arm B - Experimental Arm127

Reported measurements

Abdominal pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Control Arm22Not reportedNot reportedNot reportedNot reported
Arm B - Experimental Arm7Not reportedNot reportedNot reportedNot reported
Anemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Control Arm12Not reportedNot reportedNot reportedNot reported
Arm B - Experimental Arm16Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Control Arm4Not reportedNot reportedNot reportedNot reported
Arm B - Experimental Arm13Not reportedNot reportedNot reportedNot reported
Fatigue
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Control Arm5Not reportedNot reportedNot reportedNot reported
Arm B - Experimental Arm10Not reportedNot reportedNot reportedNot reported
Hypertension
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Control Arm6Not reportedNot reportedNot reportedNot reported
Arm B - Experimental Arm15Not reportedNot reportedNot reportedNot reported
Nausea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Control Arm14Not reportedNot reportedNot reportedNot reported
Arm B - Experimental Arm12Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Control Arm1Not reportedNot reportedNot reportedNot reported
Arm B - Experimental Arm8Not reportedNot reportedNot reportedNot reported
Rash maculo-papular
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Control Arm0Not reportedNot reportedNot reportedNot reported
Arm B - Experimental Arm9Not reportedNot reportedNot reportedNot reported
Small Intestinal Obstruction
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Control Arm9Not reportedNot reportedNot reportedNot reported
Arm B - Experimental Arm16Not reportedNot reportedNot reportedNot reported
Vomiting
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Control Arm10Not reportedNot reportedNot reportedNot reported
Arm B - Experimental Arm9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        7
    title
    Abdominal pain
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        16
    title
    Anemia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        13
    title
    Diarrhea
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        10
    title
    Fatigue
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        15
    title
    Hypertension
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        12
    title
    Nausea
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        8
    title
    Neutrophil count decreased
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        9
    title
    Rash maculo-papular
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        16
    title
    Small Intestinal Obstruction
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        9
    title
    Vomiting
denoms
  1. counts
    1. group Id
      OG000
      value
      127
    2. group Id
      OG001
      value
      127
    units
    Participants
description
Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy. Excludes AEs observed among control patients treated with trametinib after crossover.Participants were analyzed based on their group of assignment. Patients on Arm A who progressed were permitted to receive Arm B treatment. Study time for Arm A patients who crossed over was not included in the AE endpoint definition.
groups
  1. description
    Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days
    id
    OG000
    title
    Arm A - Control Arm
  2. description
    Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
    id
    OG001
    title
    Arm B - Experimental Arm
param Type
NUMBER
population Description
Treated with randomized therapy
reporting Status
POSTED
time Frame
During treatment period and up to 100 days after stopping the study treatment
title
Incidence of Adverse Events (AEs)
type
SECONDARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice