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NCT01190644 · OUTCOME

Number of Participants Who Experienced One or More Adverse Events (AEs)

Study to Evaluate Effect of a Single Dose of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Participants With Solid Tumors · Source last updated 2023-11-29

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
Up to approximately 7 months

What was measured

An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

Analysis population: All participants who received at least one dose of study treatment.

Groups in this outcome

Sotatercept

Participants received a single 35 mg dose of sotatercept by SC injection on Day 1, Day 43, and Day 85.

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

Analysis denominator · Participants

GroupSource count
Sotatercept4

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sotatercept4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
description
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
groups
  1. description
    Participants received a single 35 mg dose of sotatercept by SC injection on Day 1, Day 43, and Day 85.
    id
    OG000
    title
    Sotatercept
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants who received at least one dose of study treatment.
reporting Status
POSTED
time Frame
Up to approximately 7 months
title
Number of Participants Who Experienced One or More Adverse Events (AEs)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice