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NCT04467697 · OUTCOME

Observed and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement.

Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men · Source last updated 2024-06-28

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

Measure
MEAN
Unit
mmHg
Interval / dispersion
Standard Deviation
Time frame
Baseline, 90, 119 and 179 days

What was measured

Measured by in-clinic BP measurement of sBP, mmHg, observed and change from baseline at baseline, 90, 120 and 180 days after treatment with SOV2012-F1.

Analysis population: Extension Treated Set

Groups in this outcome

SOV2012-F1-treated, Observed

Observed systolic BP measured in-clinic at baseline, and 90, 120 and 180 days of treatment with SOV2012-F1

SOV2012-F1-treated, Change From Baseline

Change in baseline for systolic BP measured in-clinic after 90, 120 and 180 days of treatment with SOV2012-F1

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

Analysis denominator · Participants

GroupSource count
SOV2012-F1-treated, Observed155
SOV2012-F1-treated, Change From Baseline155

Reported measurements

Baseline EXT

Analysis denominator · Participants

GroupSource count
SOV2012-F1-treated, Observed152
SOV2012-F1-treated, Change From Baseline152
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
SOV2012-F1-treated, Observed126.109.800Not reportedNot reportedNot reported
SOV2012-F1-treated, Change From Baseline00Not reportedNot reportedNot reported
Visit 12E - Day 90E

Analysis denominator · Participants

GroupSource count
SOV2012-F1-treated, Observed146
SOV2012-F1-treated, Change From Baseline145
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
SOV2012-F1-treated, Observed127.899.961Not reportedNot reportedNot reported
SOV2012-F1-treated, Change From Baseline2.0610.303Not reportedNot reportedNot reported
Visit 13E - Day 119E

Analysis denominator · Participants

GroupSource count
SOV2012-F1-treated, Observed141
SOV2012-F1-treated, Change From Baseline140
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
SOV2012-F1-treated, Observed128.5110.912Not reportedNot reportedNot reported
SOV2012-F1-treated, Change From Baseline2.7010.695Not reportedNot reportedNot reported
Visit 15E - Day 179E

Analysis denominator · Participants

GroupSource count
SOV2012-F1-treated, Observed132
SOV2012-F1-treated, Change From Baseline131
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
SOV2012-F1-treated, Observed128.0910.012Not reportedNot reportedNot reported
SOV2012-F1-treated, Change From Baseline2.3910.522Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.800
        value
        126.10
      2. group Id
        OG001
        spread
        0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        152
      2. group Id
        OG001
        value
        152
      units
      Participants
    title
    Baseline EXT
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.961
        value
        127.89
      2. group Id
        OG001
        spread
        10.303
        value
        2.06
    denoms
    1. counts
      1. group Id
        OG000
        value
        146
      2. group Id
        OG001
        value
        145
      units
      Participants
    title
    Visit 12E - Day 90E
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.912
        value
        128.51
      2. group Id
        OG001
        spread
        10.695
        value
        2.70
    denoms
    1. counts
      1. group Id
        OG000
        value
        141
      2. group Id
        OG001
        value
        140
      units
      Participants
    title
    Visit 13E - Day 119E
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.012
        value
        128.09
      2. group Id
        OG001
        spread
        10.522
        value
        2.39
    denoms
    1. counts
      1. group Id
        OG000
        value
        132
      2. group Id
        OG001
        value
        131
      units
      Participants
    title
    Visit 15E - Day 179E
denoms
  1. counts
    1. group Id
      OG000
      value
      155
    2. group Id
      OG001
      value
      155
    units
    Participants
description
Measured by in-clinic BP measurement of sBP, mmHg, observed and change from baseline at baseline, 90, 120 and 180 days after treatment with SOV2012-F1.
dispersion Type
Standard Deviation
groups
  1. description
    Observed systolic BP measured in-clinic at baseline, and 90, 120 and 180 days of treatment with SOV2012-F1
    id
    OG000
    title
    SOV2012-F1-treated, Observed
  2. description
    Change in baseline for systolic BP measured in-clinic after 90, 120 and 180 days of treatment with SOV2012-F1
    id
    OG001
    title
    SOV2012-F1-treated, Change From Baseline
param Type
MEAN
population Description
Extension Treated Set
reporting Status
POSTED
time Frame
Baseline, 90, 119 and 179 days
title
Observed and Change From Baseline in Systolic Blood Pressure Using In-clinic Measurement.
type
OTHER_PRE_SPECIFIED
unit Of Measure
mmHg

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Preserved source evidence · Not medical advice