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NCT01447914 · OUTCOME

Toxicities of Single Agent Tivantinib: Grade 3 Nonhematologic or Grade 4 Hematologic Toxicities According to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4

Tivantinib in Treating Patients With Relapsed, or Relapsed and Refractory Multiple Myeloma · Source last updated 2019-08-28

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 30 days

What was measured

Toxicities with a grade 3 nonhematologic or grade 4 hematologic toxicities according to CTCAE, version 4. Grade 3 and estimated with a 95% credible interval. Summary statistics will be provided for continuous variables.

Groups in this outcome

Tivantinib Treatment

Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)

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

Analysis denominator · Participants

GroupSource count
Tivantinib Treatment16

Reported measurements

Non-Hematological Grade 3- Hypertension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tivantinib Treatment1Not reportedNot reportedNot reportedNot reported
Non Hematological Grade 3- Syncope
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tivantinib Treatment2Not reportedNot reportedNot reportedNot reported
Non Hematological Grade 3- Pulmonari emboli
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tivantinib Treatment1Not reportedNot reportedNot reportedNot reported
Hematological Grade 3- Neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tivantinib Treatment4Not reportedNot reportedNot reportedNot reported
Non Hematological Grade 3- Fatigue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tivantinib Treatment1Not reportedNot reportedNot reportedNot reported
Non Hematological Grade 3- Cough
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tivantinib Treatment1Not reportedNot reportedNot reportedNot reported
Non Hematological Grade 3- Bacteremia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tivantinib Treatment1Not reportedNot reportedNot reportedNot reported
Non Hematological Grade 3- Anorectal Infection
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tivantinib Treatment1Not reportedNot reportedNot reportedNot reported
Non Hematological Grade 3- Rectal Pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tivantinib Treatment1Not reportedNot reportedNot reportedNot reported
Non Hematological Grade 3- Rib Pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tivantinib Treatment1Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Non-Hematological Grade 3- Hypertension
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Non Hematological Grade 3- Syncope
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Non Hematological Grade 3- Pulmonari emboli
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Hematological Grade 3- Neutropenia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Non Hematological Grade 3- Fatigue
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Non Hematological Grade 3- Cough
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Non Hematological Grade 3- Bacteremia
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Non Hematological Grade 3- Anorectal Infection
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Non Hematological Grade 3- Rectal Pain
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Non Hematological Grade 3- Rib Pain
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
Toxicities with a grade 3 nonhematologic or grade 4 hematologic toxicities according to CTCAE, version 4. Grade 3 and estimated with a 95% credible interval. Summary statistics will be provided for continuous variables.
groups
  1. description
    Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
    id
    OG000
    title
    Tivantinib Treatment
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 30 days
title
Toxicities of Single Agent Tivantinib: Grade 3 Nonhematologic or Grade 4 Hematologic Toxicities According to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice