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NCT00295750 · OUTCOME

Participants Grouped by Time to Prostate-specific Antigen Failure

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

The time to prostate specific antigen failure was defined as the days from first dosing (scheduled dosing days) where an increase in serum prostate specific antigen of ≥50% from nadir and a least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted.

Analysis population: ITT population. Missing values were not imputed for this endpoint. Number in table represents the number of patients with prostate-specific antigen failure.

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

Day 0-28 (patients at risk=193, 201, 194)
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
Day 0-56 (patients at risk=192, 197, 192)
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
Day 0-84 (patients at risk=190, 193, 190)
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
Day 0-112 (patients at risk=190, 189, 188)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg1Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg1Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg3Not reportedNot reportedNot reportedNot reported
Day 0-140 (patients at risk=187, 187, 182)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg2Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg2Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg7Not reportedNot reportedNot reportedNot reported
Day 0-168 (patients at risk=179, 185, 180)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg7Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg4Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg9Not reportedNot reportedNot reportedNot reported
Day 0-196 (patients at risk=173, 181, 175)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg11Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg4Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg11Not reportedNot reportedNot reportedNot reported
Day 0-224 (patients at risk=168, 175, 173)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg14Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg7Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg12Not reportedNot reportedNot reportedNot reported
Day 0-252 (patients at risk=165, 169, 168)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg16Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg9Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg14Not reportedNot reportedNot reportedNot reported
Day 0-280 (patients at risk=157, 165, 163)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg20Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg11Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg18Not reportedNot reportedNot reportedNot reported
Day 0-308 (patients at risk=153, 161, 156)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg23Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg12Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg21Not reportedNot reportedNot reportedNot reported
Day 0-336 (patients at risk=149, 156, 150)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg26Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg15Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg24Not reportedNot reportedNot reportedNot reported
Day 0-364 (patients at risk=149, 155, 148)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg26Not reportedNot reportedNot reportedNot reported
Degarelix 240/80 mg16Not reportedNot reportedNot reportedNot reported
Leuprolide 7.5 mg26Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    79.8
    ci Pct Value
    95
    ci Upper Limit
    90.1
    estimate Comment
    95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Cumulative probability
    param Value
    85.8
    tested Non Inferiority
    false
  2. ci Lower Limit
    85.9
    ci Pct Value
    95
    ci Upper Limit
    94.5
    estimate Comment
    95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Cumulative probability
    param Value
    91.1
    tested Non Inferiority
    false
  3. ci Lower Limit
    79.9
    ci Pct Value
    95
    ci Upper Limit
    90.2
    estimate Comment
    95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.
    group Ids
    1. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Cumulative probability
    param Value
    85.9
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    79.8
    ci Pct Value
    95
    ci Upper Limit
    90.1
    estimate Comment
    95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Cumulative probability
    param Value
    85.8
    tested Non Inferiority
    false
  2. ci Lower Limit
    85.9
    ci Pct Value
    95
    ci Upper Limit
    94.5
    estimate Comment
    95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Cumulative probability
    param Value
    91.1
    tested Non Inferiority
    false
  3. ci Lower Limit
    79.9
    ci Pct Value
    95
    ci Upper Limit
    90.2
    estimate Comment
    95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.
    group Ids
    1. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Cumulative probability
    param Value
    85.9
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Day 0-28 (patients at risk=193, 201, 194)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Day 0-56 (patients at risk=192, 197, 192)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Day 0-84 (patients at risk=190, 193, 190)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
    title
    Day 0-112 (patients at risk=190, 189, 188)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        7
    title
    Day 0-140 (patients at risk=187, 187, 182)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        9
    title
    Day 0-168 (patients at risk=179, 185, 180)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        11
    title
    Day 0-196 (patients at risk=173, 181, 175)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        12
    title
    Day 0-224 (patients at risk=168, 175, 173)
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        14
    title
    Day 0-252 (patients at risk=165, 169, 168)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        18
    title
    Day 0-280 (patients at risk=157, 165, 163)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        21
    title
    Day 0-308 (patients at risk=153, 161, 156)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        15
      3. group Id
        OG002
        value
        24
    title
    Day 0-336 (patients at risk=149, 156, 150)
denoms
  1. counts
    1. group Id
      OG000
      value
      202
    2. group Id
      OG001
      value
      207
    3. group Id
      OG002
      value
      201
    units
    Participants
description
The time to prostate specific antigen failure was defined as the days from first dosing (scheduled dosing days) where an increase in serum prostate specific antigen of ≥50% from nadir and a least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted.
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. Missing values were not imputed for this endpoint. Number in table represents the number of patients with prostate-specific antigen failure.
reporting Status
POSTED
time Frame
12 months
title
Participants Grouped by Time to Prostate-specific Antigen Failure
type
SECONDARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice