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NCT00387348 · OUTCOME

Side Effect Burden

Escitalopram in Treating Depression in Patients With Advanced Lung or Gastrointestinal Cancer · Source last updated 2012-12-03

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

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
4 weeks

What was measured

Side efect burden was defined as the total score of the UKU Side Effects Rating Scale. This scale contains 48 items corresponding to side effects which are rated from 0-3, with 0 meaning not present and 1-3 rating the severity of the side effect. Higher scores represented greater side effect burden. The scale range is 0 to 144.

Analysis population: Participants who completed the 4 week assessment were analyzed

Groups in this outcome

Placebo-Placebo

Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks

Placebo-Escitalopram

Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks

Escitalopram-Placebo

Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks

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

Analysis denominator · Participants

GroupSource count
Placebo-Placebo6
Placebo-Escitalopram2
Escitalopram-Placebo9

Reported measurements

Source class 1
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-Placebo3.002.10Not reportedNot reportedNot reported
Placebo-Escitalopram2.500.71Not reportedNot reportedNot reported
Escitalopram-Placebo3.441.88Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.10
        value
        3.00
      2. group Id
        OG001
        spread
        0.71
        value
        2.50
      3. group Id
        OG002
        spread
        1.88
        value
        3.44
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      9
    units
    Participants
description
Side efect burden was defined as the total score of the UKU Side Effects Rating Scale. This scale contains 48 items corresponding to side effects which are rated from 0-3, with 0 meaning not present and 1-3 rating the severity of the side effect. Higher scores represented greater side effect burden. The scale range is 0 to 144.
dispersion Type
Standard Deviation
groups
  1. description
    Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks
    id
    OG000
    title
    Placebo-Placebo
  2. description
    Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks
    id
    OG001
    title
    Placebo-Escitalopram
  3. description
    Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks
    id
    OG002
    title
    Escitalopram-Placebo
param Type
MEAN
population Description
Participants who completed the 4 week assessment were analyzed
reporting Status
POSTED
time Frame
4 weeks
title
Side Effect Burden
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice