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NCT01502410 · OUTCOME

Pharmacokinetic (PK) Parameters of Sorafenib Tosylate

Sorafenib Tosylate in Treating Younger Patients With Relapsed or Refractory Rhabdomyosarcoma, Wilms Tumor, Liver Cancer, or Thyroid Cancer · Source last updated 2018-06-26

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

Measure
MEAN
Unit
micrograms/ml
Interval / dispersion
Full Range
Time frame
Prior to administration of Sorafenib (baseline), day 15, day 56, day 112 and day 168

What was measured

The trough sorafenib concentration is evaluated at baseline (prior to administration of Sorafenib) and 12 hours after administration of Sorafenib on day 15, day 56, day 112 and day 168 in micrograms/ml.

Analysis population: Baseline sample was available for only 9 participants.

Groups in this outcome

Rhabdomyosarcoma and Wilms Tumor

Serum concentration are the responses of the patient's organs to the drug. As such, these measures are unrelated to the particular disease with which the patient was diagnosed and were combined for analysis.

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

Analysis denominator · Participants

GroupSource count
Rhabdomyosarcoma and Wilms Tumor9

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Rhabdomyosarcoma and Wilms Tumor9
Values in micrograms/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Rhabdomyosarcoma and Wilms Tumor0Not reported00Not reported
Day 15 of protocol therapy

Analysis denominator · Participants

GroupSource count
Rhabdomyosarcoma and Wilms Tumor9
Values in micrograms/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Rhabdomyosarcoma and Wilms Tumor6.51Not reported0.0913.64Not reported
Day 56 of protocol therapy

Analysis denominator · Participants

GroupSource count
Rhabdomyosarcoma and Wilms Tumor4
Values in micrograms/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Rhabdomyosarcoma and Wilms Tumor6.99Not reported3.3310.10Not reported
Day 112 of protocol therapy

Analysis denominator · Participants

GroupSource count
Rhabdomyosarcoma and Wilms Tumor1
Values in micrograms/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Rhabdomyosarcoma and Wilms Tumor4.10Not reported4.104.10Not reported
Day 168 of protocol therapy

Analysis denominator · Participants

GroupSource count
Rhabdomyosarcoma and Wilms Tumor1
Values in micrograms/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Rhabdomyosarcoma and Wilms Tumor5.20Not reported5.205.20Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.09
        upper Limit
        13.64
        value
        6.51
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Day 15 of protocol therapy
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.33
        upper Limit
        10.10
        value
        6.99
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Day 56 of protocol therapy
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.10
        upper Limit
        4.10
        value
        4.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Day 112 of protocol therapy
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.20
        upper Limit
        5.20
        value
        5.20
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Day 168 of protocol therapy
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    units
    Participants
description
The trough sorafenib concentration is evaluated at baseline (prior to administration of Sorafenib) and 12 hours after administration of Sorafenib on day 15, day 56, day 112 and day 168 in micrograms/ml.
dispersion Type
Full Range
groups
  1. description
    Serum concentration are the responses of the patient's organs to the drug. As such, these measures are unrelated to the particular disease with which the patient was diagnosed and were combined for analysis.
    id
    OG000
    title
    Rhabdomyosarcoma and Wilms Tumor
param Type
MEAN
population Description
Baseline sample was available for only 9 participants.
reporting Status
POSTED
time Frame
Prior to administration of Sorafenib (baseline), day 15, day 56, day 112 and day 168
title
Pharmacokinetic (PK) Parameters of Sorafenib Tosylate
type
SECONDARY
unit Of Measure
micrograms/ml

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

Preserved source evidence · Not medical advice