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NCT04299048 · OUTCOME

Number of Participants With Post-Baseline Vital Signs Abnormalities

Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia. · Source last updated 2023-12-14

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From Day 1 up to Week 24

What was measured

Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the supine position. The pre-specified categorical analysis criteria in vital signs, were supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg), supine SBP increase/decrease from baseline ≥30 mmHg; supine diastolic blood pressure (DBP) \<50 mmHg, supine DBP increase/decrease from baseline ≥20 mmHg; supine pulse rate \<40 beats per minute (bpm) or \>120 bpm.

Analysis population: Overall number of participants analyzed included participants evaluated against pre-defined criteria for vital signs.

Groups in this outcome

PF-06946860 Q3W

During the 12-week treatment period, participants receive a total of 5 SC doses of PF-06946860 Q3W.

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

Analysis denominator · Participants

GroupSource count
PF-06946860 Q3W9

Reported measurements

Supine SBP - Value <90 mmHg
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W0Not reportedNot reportedNot reportedNot reported
Supine SBP - Change ≥ 30 mmHg Increase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W2Not reportedNot reportedNot reportedNot reported
Supine SBP - Change ≥ 30 mmHg Decrease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W0Not reportedNot reportedNot reportedNot reported
Supine DBP - Value <50 mmHg
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W0Not reportedNot reportedNot reportedNot reported
Supine DBP - Change ≥ 20 mmHg Increase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W1Not reportedNot reportedNot reportedNot reported
Supine DBP - Change ≥ 20 mmHg Decrease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W0Not reportedNot reportedNot reportedNot reported
Supine Pulse Rate - Value <40 bpm
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W0Not reportedNot reportedNot reportedNot reported
Supine Pulse Rate - Value >120 bpm
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PF-06946860 Q3W0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Supine SBP - Value <90 mmHg
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Supine SBP - Change ≥ 30 mmHg Increase
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Supine SBP - Change ≥ 30 mmHg Decrease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Supine DBP - Value <50 mmHg
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Supine DBP - Change ≥ 20 mmHg Increase
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Supine DBP - Change ≥ 20 mmHg Decrease
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Supine Pulse Rate - Value <40 bpm
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Supine Pulse Rate - Value >120 bpm
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    units
    Participants
description
Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the supine position. The pre-specified categorical analysis criteria in vital signs, were supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg), supine SBP increase/decrease from baseline ≥30 mmHg; supine diastolic blood pressure (DBP) \<50 mmHg, supine DBP increase/decrease from baseline ≥20 mmHg; supine pulse rate \<40 beats per minute (bpm) or \>120 bpm.
groups
  1. description
    During the 12-week treatment period, participants receive a total of 5 SC doses of PF-06946860 Q3W.
    id
    OG000
    title
    PF-06946860 Q3W
param Type
COUNT_OF_PARTICIPANTS
population Description
Overall number of participants analyzed included participants evaluated against pre-defined criteria for vital signs.
reporting Status
POSTED
time Frame
From Day 1 up to Week 24
title
Number of Participants With Post-Baseline Vital Signs Abnormalities
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice