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NCT02624388 · OUTCOME

Number of Days That Participants Are Hospitalized or Have Prolonged Hospitalization Due to an Adverse Event

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
MEAN
Unit
days
Interval / dispersion
Standard Deviation
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

Groups in this outcome

Arm A: Genistein Followed by Placebo

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 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

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 Placebo2
Arm B: Placebo Followed by Genistein2

Reported measurements

Genistein cycles
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm A: Genistein Followed by Placebo0.750.5Not reportedNot reportedNot reported
Arm B: Placebo Followed by Genistein0.50.58Not reportedNot reportedNot reported
Placebo cycles
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm A: Genistein Followed by Placebo0.50.58Not reportedNot reportedNot reported
Arm B: Placebo Followed by Genistein0.250.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.5
        value
        0.75
      2. group Id
        OG001
        spread
        0.58
        value
        0.5
    title
    Genistein cycles
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.58
        value
        0.5
      2. group Id
        OG001
        spread
        0.5
        value
        0.25
    title
    Placebo cycles
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      2
    units
    Participants
dispersion Type
Standard Deviation
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
  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
param Type
MEAN
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 Days That Participants Are Hospitalized or Have Prolonged Hospitalization Due to an Adverse Event
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice