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NCT01849874 · OUTCOME

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer · Source last updated 2023-10-30

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 the first dose of study intervention until 30 days after the last dose (up to 9 years)

What was measured

An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Analysis population: The safety set included all participants who received at least 1 dose of study intervention and had at least 1 post-treatment assessment, including death. No data was collected for the crossover set due to the early stopping of the crossover period.

Groups in this outcome

MEK162

Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study intervention.

Physician's Choice

Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one of the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m\^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m\^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study intervention.

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

Analysis denominator · Participants

GroupSource count
MEK162227
Physician's Choice106

Reported measurements

AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MEK162227Not reportedNot reportedNot reportedNot reported
Physician's Choice105Not reportedNot reportedNot reportedNot reported
SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MEK162126Not reportedNot reportedNot reportedNot reported
Physician's Choice31Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        227
      2. group Id
        OG001
        value
        105
    title
    AEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        126
      2. group Id
        OG001
        value
        31
    title
    SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      227
    2. group Id
      OG001
      value
      106
    units
    Participants
description
An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
groups
  1. description
    Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study intervention.
    id
    OG000
    title
    MEK162
  2. description
    Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one of the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m\^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m\^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study intervention.
    id
    OG001
    title
    Physician's Choice
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety set included all participants who received at least 1 dose of study intervention and had at least 1 post-treatment assessment, including death. No data was collected for the crossover set due to the early stopping of the crossover period.
reporting Status
POSTED
time Frame
From the first dose of study intervention until 30 days after the last dose (up to 9 years)
title
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice