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NCT00738582 · OUTCOME

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Amatuximab

An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma · Source last updated 2022-09-22

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 date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years

What was measured

An adverse event (AE) was any untoward medical occurrence (example; any unfavorable and unintended sign including abnormal laboratory findings, symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study until the end of study visit. TEAEs were defined as an AE that developed or worsened in severity during the on-treatment period (from first dose of amatuximab to 30 days after last dose of amatuximab). SAE was defined as any adverse event (appearance of \[or worsening of any pre-existing\]) undesirable sign, symptom or medical conditions which is fatal or life-threatening or results in persistent or significant disability/incapacity or constitutes a congenital anomaly/birth defect or requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.

Analysis population: Safety population included all participants who received at least 1 dose of amatuximab.

Groups in this outcome

Amatuximab/Pemetrexed/Cisplatin

Participants received amatuximab 5 mg/kg, IV infusion on Days 1 and 8 with pemetrexed 500 mg/m\^2, IV infusion on Day 1 and cisplatin 75 mg/ m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy (Cycle length is 21 days).

Amatuximab

Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).

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

Analysis denominator · Participants

GroupSource count
Amatuximab/Pemetrexed/Cisplatin89
Amatuximab56

Reported measurements

Participants with at least 1 TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Amatuximab/Pemetrexed/Cisplatin89Not reportedNot reportedNot reportedNot reported
Amatuximab52Not reportedNot reportedNot reportedNot reported
Participants with at least 1 SAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Amatuximab/Pemetrexed/Cisplatin38Not reportedNot reportedNot reportedNot reported
Amatuximab15Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        89
      2. group Id
        OG001
        value
        52
    title
    Participants with at least 1 TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        15
    title
    Participants with at least 1 SAE
denoms
  1. counts
    1. group Id
      OG000
      value
      89
    2. group Id
      OG001
      value
      56
    units
    Participants
description
An adverse event (AE) was any untoward medical occurrence (example; any unfavorable and unintended sign including abnormal laboratory findings, symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study until the end of study visit. TEAEs were defined as an AE that developed or worsened in severity during the on-treatment period (from first dose of amatuximab to 30 days after last dose of amatuximab). SAE was defined as any adverse event (appearance of \[or worsening of any pre-existing\]) undesirable sign, symptom or medical conditions which is fatal or life-threatening or results in persistent or significant disability/incapacity or constitutes a congenital anomaly/birth defect or requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.
groups
  1. description
    Participants received amatuximab 5 mg/kg, IV infusion on Days 1 and 8 with pemetrexed 500 mg/m\^2, IV infusion on Day 1 and cisplatin 75 mg/ m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy (Cycle length is 21 days).
    id
    OG000
    title
    Amatuximab/Pemetrexed/Cisplatin
  2. description
    Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
    id
    OG001
    title
    Amatuximab
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population included all participants who received at least 1 dose of amatuximab.
reporting Status
POSTED
time Frame
From date of first dose of study drug up to 30 days after the last dose of study treatment, up to approximately 5 years
title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Amatuximab
type
OTHER_PRE_SPECIFIED
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice