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NCT02624388 · OUTCOME

Number of Participants Who Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment

Study of Genistein in Pediatric Oncology Patients (UVA-Gen001) · Source last updated 2024-05-06

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 the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays

What was measured

This includes hearing loss/tinnitus, motor neuropathy, oral mucositis

Groups in this outcome

Arm A: Genistein Followed by Placebo - GENISTEIN Cycles

Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine

Arm B: Placebo Followed by Genistein - GENISTEIN Cycles

Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine

Arm A: Genistein Followed by Placebo - PLACEBO Cycles

Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine

Arm B: Placebo Followed by Genistein - PLACEBO Cycles

Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine

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

Analysis denominator · Participants

GroupSource count
Arm A: Genistein Followed by Placebo - GENISTEIN Cycles2
Arm B: Placebo Followed by Genistein - GENISTEIN Cycles2
Arm A: Genistein Followed by Placebo - PLACEBO Cycles2
Arm B: Placebo Followed by Genistein - PLACEBO Cycles2

Reported measurements

Genistein Cycles
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Genistein Followed by Placebo - GENISTEIN Cycles0Not reportedNot reportedNot reportedNot reported
Arm B: Placebo Followed by Genistein - GENISTEIN Cycles0Not reportedNot reportedNot reportedNot reported
Arm A: Genistein Followed by Placebo - PLACEBO Cycles0Not reportedNot reportedNot reportedNot reported
Arm B: Placebo Followed by Genistein - PLACEBO Cycles0Not reportedNot reportedNot reportedNot reported
Placebo Cycles
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Genistein Followed by Placebo - GENISTEIN Cycles0Not reportedNot reportedNot reportedNot reported
Arm B: Placebo Followed by Genistein - GENISTEIN Cycles0Not reportedNot reportedNot reportedNot reported
Arm A: Genistein Followed by Placebo - PLACEBO Cycles0Not reportedNot reportedNot reportedNot reported
Arm B: Placebo Followed by Genistein - PLACEBO Cycles0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Genistein Cycles
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Placebo Cycles
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      2
    units
    Participants
description
This includes hearing loss/tinnitus, motor neuropathy, oral mucositis
groups
  1. description
    Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine
    id
    OG000
    title
    Arm A: Genistein Followed by Placebo - GENISTEIN Cycles
  2. description
    Placebo daily throughout chemotherapy cycles 1 and 2, and genistein daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine
    id
    OG001
    title
    Arm B: Placebo Followed by Genistein - GENISTEIN Cycles
  3. description
    Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine
    id
    OG002
    title
    Arm A: Genistein Followed by Placebo - PLACEBO Cycles
  4. description
    Genistein daily throughout chemotherapy cycles 1 and 2, and placebo daily during chemotherapy cycles 3 and 4 Genistein: Estrogen-like compound (isoflavone) derived from soybeans Placebo: Pill that contains no medicine
    id
    OG003
    title
    Arm B: Placebo Followed by Genistein - PLACEBO Cycles
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
From the first date study drug is taken until the last date that study drug is taken, about 8 - 12 weeks if there are no chemotherapy delays
title
Number of Participants Who Experience Adverse Events That Are Commonly Caused by Chemotherapy Treatment
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice