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NCT02048371 · OUTCOME

The Number of Participants With Reported CTCAE (Common Terminology Criteria for Adverse Events) Version 4.03 Adverse Events. All Cohorts.

SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes · Source last updated 2023-11-07

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
up to 3 years

What was measured

Common Toxicity Criteria, also referred to as the Common Terminology Criteria for Adverse Events (CTCAE), is a standardized classification of side effects used in assessing drugs for cancer therapy. Cohorts A, B, C, and D.

Groups in this outcome

Cohort A: Liposarcoma

Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off

Cohort A: Liposarcoma, Placebo

21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off

Cohort B: Osteosarcoma

Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off

Cohort B: Osteosarcoma, Placebo

21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off

Cohort C: Ewing Sarcoma

Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off

Cohort D: Rhabdomyosarcoma

Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off

Cohort E: Mesenchymal Chondrosarcoma

Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off

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

Analysis denominator · Participants

GroupSource count
Cohort A: Liposarcoma24
Cohort A: Liposarcoma, Placebo24
Cohort B: Osteosarcoma22
Cohort B: Osteosarcoma, Placebo20
Cohort C: Ewing Sarcoma30
Cohort D: Rhabdomyosarcoma10
Cohort E: Mesenchymal Chondrosarcoma1

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: Liposarcoma12Not reportedNot reportedNot reportedNot reported
Cohort A: Liposarcoma, Placebo15Not reportedNot reportedNot reportedNot reported
Cohort B: Osteosarcoma6Not reportedNot reportedNot reportedNot reported
Cohort B: Osteosarcoma, Placebo9Not reportedNot reportedNot reportedNot reported
Cohort C: Ewing Sarcoma6Not reportedNot reportedNot reportedNot reported
Cohort D: Rhabdomyosarcoma2Not reportedNot reportedNot reportedNot reported
Cohort E: Mesenchymal Chondrosarcoma0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        15
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        9
      5. group Id
        OG004
        value
        6
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    2. group Id
      OG001
      value
      24
    3. group Id
      OG002
      value
      22
    4. group Id
      OG003
      value
      20
    5. group Id
      OG004
      value
      30
    6. group Id
      OG005
      value
      10
    7. group Id
      OG006
      value
      1
    units
    Participants
description
Common Toxicity Criteria, also referred to as the Common Terminology Criteria for Adverse Events (CTCAE), is a standardized classification of side effects used in assessing drugs for cancer therapy. Cohorts A, B, C, and D.
groups
  1. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    OG000
    title
    Cohort A: Liposarcoma
  2. description
    21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off
    id
    OG001
    title
    Cohort A: Liposarcoma, Placebo
  3. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    OG002
    title
    Cohort B: Osteosarcoma
  4. description
    21 days on and 7 days off Placebo Placebo: 21 days on and 7 days off
    id
    OG003
    title
    Cohort B: Osteosarcoma, Placebo
  5. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    OG004
    title
    Cohort C: Ewing Sarcoma
  6. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    OG005
    title
    Cohort D: Rhabdomyosarcoma
  7. description
    Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    OG006
    title
    Cohort E: Mesenchymal Chondrosarcoma
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
up to 3 years
title
The Number of Participants With Reported CTCAE (Common Terminology Criteria for Adverse Events) Version 4.03 Adverse Events. All Cohorts.
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice