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NCT00295750 · OUTCOME

Participants With Markedly Abnormal Change in Vital Signs and Body Weight

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
12 months

What was measured

Vital signs and body weight included incidence of markedly abnormal changes from baseline to the end of the study in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.

Analysis population: ITT population. The first value in the category represents the actual clinical reading and the second is the change from baseline for blood pressure (units: millimeters of mercury) and heart rate (units:beats per minute). The weight category includes patients whose percent weight change from baseline fit the stated ranges.

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

Systolic blood pressure <=90 and decrease >=20
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg12Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg8Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg6Not reportedNot reportedNot reportedNot reported
Systolic blood pressure >=180 and increase >=20
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg20Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg16Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg23Not reportedNot reportedNot reportedNot reported
Diastolic blood pressure <=50 and decrease >=15
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg12Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg10Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg9Not reportedNot reportedNot reportedNot reported
Diastolic blood pressure >=105 and increase >=15
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg5Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg13Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg8Not reportedNot reportedNot reportedNot reported
Heart rate <=50 and decrease >=15
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg8Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg7Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg9Not reportedNot reportedNot reportedNot reported
Heart rate >=120 and increase >=15
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg1Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg0Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg1Not reportedNot reportedNot reportedNot reported
Body weight decrease of >=7 percent
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg5Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg6Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg10Not reportedNot reportedNot reportedNot reported
Body weight increase of >=7 percent
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg24Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg15Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg23Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        6
    title
    Systolic blood pressure <=90 and decrease >=20
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        16
      3. group Id
        OG002
        value
        23
    title
    Systolic blood pressure >=180 and increase >=20
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        9
    title
    Diastolic blood pressure <=50 and decrease >=15
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        8
    title
    Diastolic blood pressure >=105 and increase >=15
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        9
    title
    Heart rate <=50 and decrease >=15
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Heart rate >=120 and increase >=15
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        10
    title
    Body weight decrease of >=7 percent
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        15
      3. group Id
        OG002
        value
        23
    title
    Body weight increase of >=7 percent
denoms
  1. counts
    1. group Id
      OG000
      value
      202
    2. group Id
      OG001
      value
      207
    3. group Id
      OG002
      value
      201
    units
    Participants
description
Vital signs and body weight included incidence of markedly abnormal changes from baseline to the end of the study in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.
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. The first value in the category represents the actual clinical reading and the second is the change from baseline for blood pressure (units: millimeters of mercury) and heart rate (units:beats per minute). The weight category includes patients whose percent weight change from baseline fit the stated ranges.
reporting Status
POSTED
time Frame
12 months
title
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice