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NCT01631552 · OUTCOME

Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events

Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer · Source last updated 2021-08-12

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months) plus 30 days

What was measured

Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.03. An AE that met one or more of the following outcomes was classified as serious: * Fatal * Life-threatening * Disabling/incapacitating * Results in hospitalization or prolongs a hospital stay * A congenital abnormality * Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population.

Analysis population: * Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease \& who received at least 1 dose of 10 mg/kg SG * HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy \& who received at least 1 dose of 10 mg/kg SG * mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments \& who received at least 1 dose of 10 mg/kg SG * OSP: All participants who received at least 1 dose of SG

Groups in this outcome

TNBC Target Population

Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.

HR+/HER2- mBC Population

Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as Hormone receptor-positive/Human epidermal growth factor receptor 2-negative (HR+/HER2-), had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.

mUC Population

Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population.

Overall Safety Population (OSP)

Overall 495 participants were enrolled in the study and received at least one dose of 10 mg/kg, 8 mg/kg, 12mg/kg, or 18mg/kg SG. These participants were included in the Overall Safety Population and analyzed for safety.

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

Analysis denominator · Participants

GroupSource count
TNBC Target Population108
HR+/HER2- mBC Population54
mUC Population45
Overall Safety Population (OSP)495

Reported measurements

Adverse Events
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TNBC Target Population100.0Not reportedNot reportedNot reportedNot reported
HR+/HER2- mBC Population100.0Not reportedNot reportedNot reportedNot reported
mUC Population100.0Not reportedNot reportedNot reportedNot reported
Overall Safety Population (OSP)99.8Not reportedNot reportedNot reportedNot reported
Serious Adverse Events
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TNBC Target Population30.6Not reportedNot reportedNot reportedNot reported
HR+/HER2- mBC Population35.2Not reportedNot reportedNot reportedNot reported
mUC Population42.2Not reportedNot reportedNot reportedNot reported
Overall Safety Population (OSP)38.8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100.0
      2. group Id
        OG001
        value
        100.0
      3. group Id
        OG002
        value
        100.0
      4. group Id
        OG003
        value
        99.8
    title
    Adverse Events
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        30.6
      2. group Id
        OG001
        value
        35.2
      3. group Id
        OG002
        value
        42.2
      4. group Id
        OG003
        value
        38.8
    title
    Serious Adverse Events
denoms
  1. counts
    1. group Id
      OG000
      value
      108
    2. group Id
      OG001
      value
      54
    3. group Id
      OG002
      value
      45
    4. group Id
      OG003
      value
      495
    units
    Participants
description
Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.03. An AE that met one or more of the following outcomes was classified as serious: * Fatal * Life-threatening * Disabling/incapacitating * Results in hospitalization or prolongs a hospital stay * A congenital abnormality * Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population.
groups
  1. description
    Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
    id
    OG000
    title
    TNBC Target Population
  2. description
    Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as Hormone receptor-positive/Human epidermal growth factor receptor 2-negative (HR+/HER2-), had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.
    id
    OG001
    title
    HR+/HER2- mBC Population
  3. description
    Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population.
    id
    OG002
    title
    mUC Population
  4. description
    Overall 495 participants were enrolled in the study and received at least one dose of 10 mg/kg, 8 mg/kg, 12mg/kg, or 18mg/kg SG. These participants were included in the Overall Safety Population and analyzed for safety.
    id
    OG003
    title
    Overall Safety Population (OSP)
param Type
NUMBER
population Description
* Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease \& who received at least 1 dose of 10 mg/kg SG * HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy \& who received at least 1 dose of 10 mg/kg SG * mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments \& who received at least 1 dose of 10 mg/kg SG * OSP: All participants who received at least 1 dose of SG
reporting Status
POSTED
time Frame
First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months) plus 30 days
title
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice