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NCT00510068 · OUTCOME

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs)

Efficacy and Safety of Everolimus (RAD001) Compared to Placebo in Patients With Advanced Neuroendocrine Tumors · Source last updated 2015-07-01

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
on or after the start of double-blind study medication until no later than 28 days after double-blind study medication discontinuation

What was measured

Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

Analysis population: The Safety Set consists of all patients who received any study drug and had at least one post-baseline safety assessment.

Groups in this outcome

Everolimus 10 mg/Day

Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).

Placebo

Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).

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

Analysis denominator · Participants

GroupSource count
Everolimus 10 mg/Day204
Placebo203

Reported measurements

Adverse events (AEs)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus 10 mg/Day203Not reportedNot reportedNot reportedNot reported
Placebo198Not reportedNot reportedNot reportedNot reported
Death
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus 10 mg/Day111Not reportedNot reportedNot reportedNot reported
Placebo23Not reportedNot reportedNot reportedNot reported
Serious Adverse Events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus 10 mg/Day84Not reportedNot reportedNot reportedNot reported
Placebo52Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        203
      2. group Id
        OG001
        value
        198
    title
    Adverse events (AEs)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        111
      2. group Id
        OG001
        value
        23
    title
    Death
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        84
      2. group Id
        OG001
        value
        52
    title
    Serious Adverse Events
denoms
  1. counts
    1. group Id
      OG000
      value
      204
    2. group Id
      OG001
      value
      203
    units
    Participants
description
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
groups
  1. description
    Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
    id
    OG000
    title
    Everolimus 10 mg/Day
  2. description
    Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
    id
    OG001
    title
    Placebo
param Type
NUMBER
population Description
The Safety Set consists of all patients who received any study drug and had at least one post-baseline safety assessment.
reporting Status
POSTED
time Frame
on or after the start of double-blind study medication until no later than 28 days after double-blind study medication discontinuation
title
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs)
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice