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NCT02354508 · OUTCOME

Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline

Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues · Source last updated 2019-12-10

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
Weeks 48, 60 & 72

What was measured

Symptoms of acromegaly were collected at various visits. The measurement was to be provided on a scale of 1-15 including half sizes. Investigators asked the participants to score the following symptoms of acromegaly: headache, fatigue, perspiration, paresthesias, osteoarthralgia according to a five-point score scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe).

Analysis population: Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.

Groups in this outcome

Pasireotide LAR Overall - Acromegaly Symptom: Headache

This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

Pasireotide LAR Overall - Acromegaly Symptom: Fatigue

This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

Pasireotide LAR Overall - Acromegaly Symptom: Perspiration

This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia

This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae

This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase

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

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall - Acromegaly Symptom: Headache88
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue88
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration88
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia88
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae88

Reported measurements

Ext. Baseline (BL): Non/absent

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall - Acromegaly Symptom: Headache61
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue50
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration60
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia46
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae70
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall - Acromegaly Symptom: Headache69.3Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue56.8Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration68.2Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia52.3Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae79.5Not reportedNot reportedNot reportedNot reported
Ext. BL: Mild

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall - Acromegaly Symptom: Headache18
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue21
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration18
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia27
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae12
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall - Acromegaly Symptom: Headache20.5Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue23.9Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration20.5Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia30.7Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae13.6Not reportedNot reportedNot reportedNot reported
Ext. BL: Moderate

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall - Acromegaly Symptom: Headache8
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue11
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration9
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia11
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae5
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall - Acromegaly Symptom: Headache9.1Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue12.5Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration10.2Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia12.5Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae5.7Not reportedNot reportedNot reportedNot reported
Ext. BL: Severe

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall - Acromegaly Symptom: Headache1
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue4
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration1
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia3
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae0
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall - Acromegaly Symptom: Headache1.1Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue4.5Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration1.1Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia3.4Not reportedNot reportedNot reportedNot reported
Ext. BL: Very severe

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall - Acromegaly Symptom: Headache0
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue2
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration0
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia1
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue2.3Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia1.1Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae1.1Not reportedNot reportedNot reportedNot reported
Ext. BL: Not done

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall - Acromegaly Symptom: Headache0
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue0
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration0
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia0
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae0
Ext. BL: Total

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall - Acromegaly Symptom: Headache88
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue88
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration88
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia88
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae88
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall - Acromegaly Symptom: Headache100.0Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue100.0Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration100.0Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia100.0Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae100.0Not reportedNot reportedNot reportedNot reported
Most extr. post-BL:tot Non/absent

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall - Acromegaly Symptom: Headache41
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue45
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration48
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia38
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae59
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall - Acromegaly Symptom: Headache46.6Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue51.1Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration54.5Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia43.2Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae67.0Not reportedNot reportedNot reportedNot reported
Most extr. post-BL: total Mild

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall - Acromegaly Symptom: Headache26
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue20
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration23
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia29
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae20
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall - Acromegaly Symptom: Headache29.5Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue22.7Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration26.1Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia33.0Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae22.7Not reportedNot reportedNot reportedNot reported
Most extr. post-BL: total Mod.

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall - Acromegaly Symptom: Headache16
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue16
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration13
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia12
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae6
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall - Acromegaly Symptom: Headache18.2Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue18.2Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration14.8Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia13.6Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae6.8Not reportedNot reportedNot reportedNot reported
Most extr. post-BL: total Severe

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall - Acromegaly Symptom: Headache3
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue6
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration4
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia7
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae2
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall - Acromegaly Symptom: Headache3.4Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue6.8Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration4.5Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia8.0Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae2.3Not reportedNot reportedNot reportedNot reported
Most extr. post-BL: tot. Very severe

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall - Acromegaly Symptom: Headache2
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue1
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration0
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia2
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pasireotide LAR Overall - Acromegaly Symptom: Headache2.3Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue1.1Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia2.3Not reportedNot reportedNot reportedNot reported
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae1.1Not reportedNot reportedNot reportedNot reported
Most extr. post-BL: total Not done

Analysis denominator · Participants

GroupSource count
Pasireotide LAR Overall - Acromegaly Symptom: Headache0
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue0
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration0
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia0
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae0
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        69.3
      2. group Id
        OG001
        value
        56.8
      3. group Id
        OG002
        value
        68.2
      4. group Id
        OG003
        value
        52.3
      5. group Id
        OG004
        value
        79.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        61
      2. group Id
        OG001
        value
        50
      3. group Id
        OG002
        value
        60
      4. group Id
        OG003
        value
        46
      5. group Id
        OG004
        value
        70
      units
      Participants
    title
    Ext. Baseline (BL): Non/absent
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        20.5
      2. group Id
        OG001
        value
        23.9
      3. group Id
        OG002
        value
        20.5
      4. group Id
        OG003
        value
        30.7
      5. group Id
        OG004
        value
        13.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        21
      3. group Id
        OG002
        value
        18
      4. group Id
        OG003
        value
        27
      5. group Id
        OG004
        value
        12
      units
      Participants
    title
    Ext. BL: Mild
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        9.1
      2. group Id
        OG001
        value
        12.5
      3. group Id
        OG002
        value
        10.2
      4. group Id
        OG003
        value
        12.5
      5. group Id
        OG004
        value
        5.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        11
      5. group Id
        OG004
        value
        5
      units
      Participants
    title
    Ext. BL: Moderate
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1.1
      2. group Id
        OG001
        value
        4.5
      3. group Id
        OG002
        value
        1.1
      4. group Id
        OG003
        value
        3.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    Ext. BL: Severe
  5. categories
    1. measurements
      1. group Id
        OG001
        value
        2.3
      2. group Id
        OG003
        value
        1.1
      3. group Id
        OG004
        value
        1.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    Ext. BL: Very severe
  6. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    Ext. BL: Not done
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        100.0
      2. group Id
        OG001
        value
        100.0
      3. group Id
        OG002
        value
        100.0
      4. group Id
        OG003
        value
        100.0
      5. group Id
        OG004
        value
        100.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        88
      2. group Id
        OG001
        value
        88
      3. group Id
        OG002
        value
        88
      4. group Id
        OG003
        value
        88
      5. group Id
        OG004
        value
        88
      units
      Participants
    title
    Ext. BL: Total
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        46.6
      2. group Id
        OG001
        value
        51.1
      3. group Id
        OG002
        value
        54.5
      4. group Id
        OG003
        value
        43.2
      5. group Id
        OG004
        value
        67.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        41
      2. group Id
        OG001
        value
        45
      3. group Id
        OG002
        value
        48
      4. group Id
        OG003
        value
        38
      5. group Id
        OG004
        value
        59
      units
      Participants
    title
    Most extr. post-BL:tot Non/absent
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        29.5
      2. group Id
        OG001
        value
        22.7
      3. group Id
        OG002
        value
        26.1
      4. group Id
        OG003
        value
        33.0
      5. group Id
        OG004
        value
        22.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        23
      4. group Id
        OG003
        value
        29
      5. group Id
        OG004
        value
        20
      units
      Participants
    title
    Most extr. post-BL: total Mild
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        18.2
      2. group Id
        OG001
        value
        18.2
      3. group Id
        OG002
        value
        14.8
      4. group Id
        OG003
        value
        13.6
      5. group Id
        OG004
        value
        6.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        16
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        12
      5. group Id
        OG004
        value
        6
      units
      Participants
    title
    Most extr. post-BL: total Mod.
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        3.4
      2. group Id
        OG001
        value
        6.8
      3. group Id
        OG002
        value
        4.5
      4. group Id
        OG003
        value
        8.0
      5. group Id
        OG004
        value
        2.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        2
      units
      Participants
    title
    Most extr. post-BL: total Severe
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        2.3
      2. group Id
        OG001
        value
        1.1
      3. group Id
        OG003
        value
        2.3
      4. group Id
        OG004
        value
        1.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    Most extr. post-BL: tot. Very severe
denoms
  1. counts
    1. group Id
      OG000
      value
      88
    2. group Id
      OG001
      value
      88
    3. group Id
      OG002
      value
      88
    4. group Id
      OG003
      value
      88
    5. group Id
      OG004
      value
      88
    units
    Participants
description
Symptoms of acromegaly were collected at various visits. The measurement was to be provided on a scale of 1-15 including half sizes. Investigators asked the participants to score the following symptoms of acromegaly: headache, fatigue, perspiration, paresthesias, osteoarthralgia according to a five-point score scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe).
groups
  1. description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
    id
    OG000
    title
    Pasireotide LAR Overall - Acromegaly Symptom: Headache
  2. description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
    id
    OG001
    title
    Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
  3. description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
    id
    OG002
    title
    Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
  4. description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
    id
    OG003
    title
    Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
  5. description
    This is the sum total of participants who were treated with at least one dose of pasireotide LAR in the extension phase
    id
    OG004
    title
    Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
param Type
NUMBER
population Description
Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.
reporting Status
POSTED
time Frame
Weeks 48, 60 & 72
title
Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice