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NCT02301039 · OUTCOME

Adverse Events Related to Pembrolizumab Treatment in Patients With Advanced Sarcoma, by Patient

SARC028: A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced Sarcomas · Source last updated 2020-09-29

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

Measure
NUMBER
Unit
Grade 3 or higher treatment related AEs
Interval / dispersion
Not reported
Time frame
Up to 5 years

What was measured

Related Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a investigational product and related to the investigational product.

Groups in this outcome

Soft Tissue Sarcoma

Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab

Bone Sarcoma

Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab

Expansion Cohort

Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks

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

Analysis denominator · Participants

GroupSource count
Soft Tissue Sarcoma42
Bone Sarcoma42
Expansion Cohort60

Reported measurements

Source class 1
Values in Grade 3 or higher treatment related AEs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Soft Tissue Sarcoma6Not reportedNot reportedNot reportedNot reported
Bone Sarcoma9Not reportedNot reportedNot reportedNot reported
Expansion Cohort10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        10
denoms
  1. counts
    1. group Id
      OG000
      value
      42
    2. group Id
      OG001
      value
      42
    3. group Id
      OG002
      value
      60
    units
    Participants
description
Related Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a investigational product and related to the investigational product.
groups
  1. description
    Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab
    id
    OG000
    title
    Soft Tissue Sarcoma
  2. description
    Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab
    id
    OG001
    title
    Bone Sarcoma
  3. description
    Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks
    id
    OG002
    title
    Expansion Cohort
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 5 years
title
Adverse Events Related to Pembrolizumab Treatment in Patients With Advanced Sarcoma, by Patient
type
SECONDARY
unit Of Measure
Grade 3 or higher treatment related AEs

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

Preserved source evidence · Not medical advice