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NCT00412061 · OUTCOME

Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase)

Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor · Source last updated 2014-11-21

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

Measure
NUMBER
Unit
Patients
Interval / dispersion
Not reported
Time frame
From first day of treatment up to 28 days after last day of treatment in double blind

What was measured

AEs 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. SAEs 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 at least one dose of study drug and who had at least one valid post-baseline safety assessment.

Groups in this outcome

Everolimus Open Label Arm

Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.

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 Open Label Arm170

Reported measurements

Clinically notable AE
Values in Patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus Open Label Arm154Not reportedNot reportedNot reportedNot reported
Grade 3-4 Adverse Events
Values in Patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus Open Label Arm115Not reportedNot reportedNot reportedNot reported
On treatment death
Values in Patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus Open Label Arm22Not reportedNot reportedNot reportedNot reported
Serious adverse events
Values in Patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus Open Label Arm93Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        154
    title
    Clinically notable AE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        115
    title
    Grade 3-4 Adverse Events
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        22
    title
    On treatment death
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        93
    title
    Serious adverse events
denoms
  1. counts
    1. group Id
      OG000
      value
      170
    units
    Participants
description
AEs 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. SAEs 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
    Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
    id
    OG000
    title
    Everolimus Open Label Arm
param Type
NUMBER
population Description
The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment.
reporting Status
POSTED
time Frame
From first day of treatment up to 28 days after last day of treatment in double blind
title
Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase)
type
SECONDARY
unit Of Measure
Patients

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

Preserved source evidence · Not medical advice