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NCT00295750 · OUTCOME

Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)

The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer · Source last updated 2012-12-19

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Baseline to Day 364

What was measured

Criteria for lab values changes from baseline to the end of the study considered markedly abnormal were set for each lab test. If 20% of patients reached that value, the results were reported.

Analysis population: ITT population

Groups in this outcome

Degarelix 240/160 mg

Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.

Degarelix 240/80 mg

Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.

Leuprolide 7.5 mg

Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.

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

Analysis denominator · Participants

GroupSource count
Degarelix 240/160 mg202
Degarelix 240/80 mg207
Leuprolide 7.5 mg201

Reported measurements

Haematocrit (<=0.37 ratio)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg73Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg80Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg73Not reportedNot reportedNot reportedNot reported
Haemoglobin (<=115 g/L)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg32Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg45Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg38Not reportedNot reportedNot reportedNot reported
Serum Urea Nitrogen (>=10.7 mmol/L)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg48Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg41Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg50Not reportedNot reportedNot reportedNot reported
Urine Protein (>=2 units from baseline)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg65Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg64Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg63Not reportedNot reportedNot reportedNot reported
Urine Bacteria (0 at baseline and >0 on treatment)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg96Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg105Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg107Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        73
      2. group Id
        OG001
        value
        80
      3. group Id
        OG002
        value
        73
    title
    Haematocrit (<=0.37 ratio)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        45
      3. group Id
        OG002
        value
        38
    title
    Haemoglobin (<=115 g/L)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        48
      2. group Id
        OG001
        value
        41
      3. group Id
        OG002
        value
        50
    title
    Serum Urea Nitrogen (>=10.7 mmol/L)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        65
      2. group Id
        OG001
        value
        64
      3. group Id
        OG002
        value
        63
    title
    Urine Protein (>=2 units from baseline)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        96
      2. group Id
        OG001
        value
        105
      3. group Id
        OG002
        value
        107
    title
    Urine Bacteria (0 at baseline and >0 on treatment)
denoms
  1. counts
    1. group Id
      OG000
      value
      202
    2. group Id
      OG001
      value
      207
    3. group Id
      OG002
      value
      201
    units
    Participants
description
Criteria for lab values changes from baseline to the end of the study considered markedly abnormal were set for each lab test. If 20% of patients reached that value, the results were reported.
groups
  1. description
    Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
    id
    OG000
    title
    Degarelix 240/160 mg
  2. description
    Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
    id
    OG001
    title
    Degarelix 240/80 mg
  3. description
    Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
    id
    OG002
    title
    Leuprolide 7.5 mg
param Type
NUMBER
population Description
ITT population
reporting Status
POSTED
time Frame
Baseline to Day 364
title
Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice