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NCT04467697 · OUTCOME

Observed and Change From Baseline in Heartrate (HR) Obtained In-clinic During the Treatment Period.

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
beats/minute
Interval / dispersion
Standard Deviation
Time frame
Baseline, 90, 119 and 179 days

What was measured

Measured by in-clinic HR measurement, beats per minute during the treatment period, at baseline, and after 90, 120 and 180 days of treatment with SOV2012-F1.

Analysis population: Extension Treated Set

Groups in this outcome

SOV2012-F1-treated, Observed

Observed heartrate (HR) measured in-clinic at baseline, and 90, 120 and 180 days of treatment with SOV2012-F1.

SOV2012-F1-treated, Change From Baseline

Change from baseline for heartrate (HR) measured in-clinic at 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, Observed155
SOV2012-F1-treated, Change From Baseline155
Values in beats/minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
SOV2012-F1-treated, Observed71.99.48Not 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 Baseline146
Values in beats/minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
SOV2012-F1-treated, Observed73.99.42Not reportedNot reportedNot reported
SOV2012-F1-treated, Change From Baseline1.99.09Not reportedNot reportedNot reported
Visit 13E - Day 119E

Analysis denominator · Participants

GroupSource count
SOV2012-F1-treated, Observed141
SOV2012-F1-treated, Change From Baseline141
Values in beats/minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
SOV2012-F1-treated, Observed72.99.40Not reportedNot reportedNot reported
SOV2012-F1-treated, Change From Baseline1.19.13Not reportedNot reportedNot reported
Visit 15E - Day 179E

Analysis denominator · Participants

GroupSource count
SOV2012-F1-treated, Observed132
SOV2012-F1-treated, Change From Baseline132
Values in beats/minute · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
SOV2012-F1-treated, Observed74.310.26Not reportedNot reportedNot reported
SOV2012-F1-treated, Change From Baseline2.69.37Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.48
        value
        71.9
      2. group Id
        OG001
        spread
        0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        155
      2. group Id
        OG001
        value
        155
      units
      Participants
    title
    Baseline EXT
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.42
        value
        73.9
      2. group Id
        OG001
        spread
        9.09
        value
        1.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        146
      2. group Id
        OG001
        value
        146
      units
      Participants
    title
    Visit 12E - Day 90E
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.40
        value
        72.9
      2. group Id
        OG001
        spread
        9.13
        value
        1.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        141
      2. group Id
        OG001
        value
        141
      units
      Participants
    title
    Visit 13E - Day 119E
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.26
        value
        74.3
      2. group Id
        OG001
        spread
        9.37
        value
        2.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        132
      2. group Id
        OG001
        value
        132
      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 HR measurement, beats per minute during the treatment period, at baseline, and after 90, 120 and 180 days of treatment with SOV2012-F1.
dispersion Type
Standard Deviation
groups
  1. description
    Observed heartrate (HR) 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 from baseline for heartrate (HR) measured in-clinic at 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 Heartrate (HR) Obtained In-clinic During the Treatment Period.
type
OTHER_PRE_SPECIFIED
unit Of Measure
beats/minute

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Preserved source evidence · Not medical advice