ID

35672

Description

Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Keywords

  1. 3/15/19 3/15/19 -
Copyright Holder

GSK group of companies

Uploaded on

March 15, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369

Quality of Life

  1. StudyEvent: ODM
    1. Quality of Life
Administrative data
Description

Administrative data

Name
Description

Name

Data type

text

Today's Date
Description

Date

Data type

date

Protocol Number
Description

Protocol Number

Data type

integer

Physical well-being
Description

Physical well-being

I have a lack of energy
Description

lack of energy

Data type

text

I have nausea
Description

nausea

Data type

text

Because of my physical condition, I have trouble meeting the needs of my family
Description

Trouble meeting family needs

Data type

text

I have pain
Description

Pain

Data type

text

I am bothered by side effects of treatment
Description

side effects of treatment

Data type

text

I feel ill
Description

feeling ill

Data type

text

I am forced to spend time in bed
Description

bed rest

Data type

text

Social/Family Well-Being
Description

Social/Family Well-Being

I feel close to my friends
Description

closeness to friends

Data type

text

I get emotional support from my family
Description

family emotional support

Data type

text

I get support from my friends and neighbors
Description

Support from friends and neighbours

Data type

text

My family has accepted my illness
Description

illness acceptance by family

Data type

text

I am satisfied with family communication about my illness
Description

family communication about illness

Data type

text

I feel close to my partner (or the person who is my main support)
Description

closeness to main supporting family member

Data type

text

I am satisfied with my sex life
Description

If you prefer not to answer this question, just skip it and go to the next section.

Data type

text

Emotional Well-Being
Description

Emotional Well-Being

I feel sad
Description

feeling sad

Data type

text

I am satisfied with how I am coping with my illness
Description

satisfactory coping with illness

Data type

text

I am loosing hope in the fight against my illness
Description

loss of hope

Data type

text

I feel nervous
Description

feeling nervous

Data type

text

I worry about dying
Description

fear of death

Data type

text

I worry that my condition will get worse
Description

worry about worsening condition

Data type

text

Functional Well-Being
Description

Functional Well-Being

I am able to work (include work at home)
Description

ability to work

Data type

text

my work (include work a home) is fulfilling
Description

work is fulfilling

Data type

text

I am able to enjoy life
Description

able to enjoy life

Data type

text

I have accepted my illness
Description

acceptance of illness

Data type

text

I am sleeping well
Description

sleep

Data type

text

I am enjoying things I usually do for fun
Description

enjoying leisure activities

Data type

text

I am content with the quality of my life right now
Description

content with life quality

Data type

text

Please rate your overall quality of life
Description

lowest quality 0 highest quality 100

Data type

integer

Additional Concerns
Description

Additional Concerns

I am bothered by discharge or bleeding from my vagina
Description

vaginal bleeding

Data type

text

I am bothered by odor coming from my vagina
Description

vaginal odor

Data type

text

I am afraid to have sex
Description

fear of sexual contact

Data type

text

I feel sexually attractive
Description

sexual attractiveness

Data type

text

My vagina feels too narrow or short
Description

vagina narrow

Data type

text

I have concerns about my ability to have children
Description

concern about child bearing potential

Data type

text

I am afraid the treatment may harm my body
Description

fear of treatment harm

Data type

text

I am interested in having sex
Description

interest in sex

Data type

text

I like the appearance of my body
Description

body dissatisfaction

Data type

text

I am bothered by constipation
Description

constipation

Data type

text

I have a good appetite
Description

appetite

Data type

text

I have trouble controlling my urine
Description

urine control

Data type

text

It burns when I urinate
Description

burning while urinating

Data type

text

I have discomfort when I urinate
Description

discomfort while urinating

Data type

text

I am able to eat the foods that I like
Description

dietary preferences

Data type

text

I have numbness or tingling in my hands
Description

numbness / tingling hands

Data type

text

I have numbness or tingling in my feet
Description

numbness / tingling feet

Data type

text

I have joint pain or muscle cramps
Description

joint pain / muscle cramps

Data type

text

I feel weak all over
Description

weakness

Data type

text

I have trouble hearing
Description

hearing problems

Data type

text

I get a ringing or buzzing in my ears
Description

ringing / buzzing ears

Data type

text

I have trouble buttoning buttons
Description

hand coordination

Data type

text

I have trouble feeling the shape of small objects when they are in my hand
Description

Hypoaesthesia

Data type

text

I have trouble walking
Description

Paraparesis

Data type

text

Brief Pain Inventory
Description

Brief Pain Inventory

Brief Pain Inventory
Description

Brief Pain Inventory

Brief Pain Inventory (Please rate your pain on the scale from 1 to 10 that best describes your pain at its worst on the average)
Description

Brief Pain Inventory

Data type

float

Brief Pain Inventory (Please rate your pain on the scale from 1 to 10 that best describes your pain at its worst right now)
Description

Brief Pain Inventory

Data type

float

What treatments or medications are you receiving for your pain?
Description

painkillers and treatment

Data type

text

In the last 24 hours how much relief have pain medications provided?
Description

Please mark the one percentage that most shows how much relief you have received

Data type

integer

Measurement units
  • %
%
Brief Pain Inventory (Please rate your pain on the scale from 1 to 10 that best describes your pain at its worst in the last 24 hours)
Description

(No pain - 0; Pain as bad as you can imagine - 10)

Data type

float

Pain Interference
Description

Pain Interference

Mark how during the past 24 hours pain has interfered with your:
Description

choose type of activity

Data type

text

Interference scale
Description

1 - does not interfere 10 - completely interferes

Data type

text

Similar models

Quality of Life

  1. StudyEvent: ODM
    1. Quality of Life
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Name
Item
Name
text
Date
Item
Today's Date
date
Protocol Number
Item
Protocol Number
integer
Item Group
Physical well-being
Item
I have a lack of energy
text
Code List
I have a lack of energy
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have nausea
text
Code List
I have nausea
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
Because of my physical condition, I have trouble meeting the needs of my family
text
Code List
Because of my physical condition, I have trouble meeting the needs of my family
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have pain
text
Code List
I have pain
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am bothered by side effects of treatment
text
Code List
I am bothered by side effects of treatment
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I feel ill
text
Code List
I feel ill
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am forced to spend time in bed
text
Code List
I am forced to spend time in bed
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I feel close to my friends
text
Code List
I feel close to my friends
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I get emotional support from my family
text
Code List
I get emotional support from my family
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I get support from my friends and neighbors
text
Code List
I get support from my friends and neighbors
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
My family has accepted my illness
text
Code List
My family has accepted my illness
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am satisfied with family communication about my illness
text
Code List
I am satisfied with family communication about my illness
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I feel close to my partner (or the person who is my main support)
text
Code List
I feel close to my partner (or the person who is my main support)
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am satisfied with my sex life
text
Code List
I am satisfied with my sex life
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item Group
Emotional Well-Being
Item
I feel sad
text
Code List
I feel sad
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am satisfied with how I am coping with my illness
text
Code List
I am satisfied with how I am coping with my illness
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am loosing hope in the fight against my illness
text
Code List
I am loosing hope in the fight against my illness
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I feel nervous
text
Code List
I feel nervous
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I worry about dying
text
Code List
I worry about dying
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I worry that my condition will get worse
text
Code List
I worry that my condition will get worse
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item Group
Functional Well-Being
Item
I am able to work (include work at home)
text
Code List
I am able to work (include work at home)
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
my work (include work a home) is fulfilling
text
Code List
my work (include work a home) is fulfilling
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am able to enjoy life
text
Code List
I am able to enjoy life
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have accepted my illness
text
Code List
I have accepted my illness
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am sleeping well
text
Code List
I am sleeping well
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am enjoying things I usually do for fun
text
Code List
I am enjoying things I usually do for fun
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am content with the quality of my life right now
text
Code List
I am content with the quality of my life right now
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
overall quality of life
Item
Please rate your overall quality of life
integer
Item Group
Additional Concerns
Item
I am bothered by discharge or bleeding from my vagina
text
Code List
I am bothered by discharge or bleeding from my vagina
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am bothered by odor coming from my vagina
text
Code List
I am bothered by odor coming from my vagina
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am afraid to have sex
text
Code List
I am afraid to have sex
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I feel sexually attractive
text
Code List
I feel sexually attractive
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
My vagina feels too narrow or short
text
Code List
My vagina feels too narrow or short
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have concerns about my ability to have children
text
Code List
I have concerns about my ability to have children
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am afraid the treatment may harm my body
text
Code List
I am afraid the treatment may harm my body
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am interested in having sex
text
Code List
I am interested in having sex
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I like the appearance of my body
text
Code List
I like the appearance of my body
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am bothered by constipation
text
Code List
I am bothered by constipation
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have a good appetite
text
Code List
I have a good appetite
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have trouble controlling my urine
text
Code List
I have trouble controlling my urine
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
It burns when I urinate
text
Code List
It burns when I urinate
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have discomfort when I urinate
text
Code List
I have discomfort when I urinate
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I am able to eat the foods that I like
text
Code List
I am able to eat the foods that I like
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have numbness or tingling in my hands
text
Code List
I have numbness or tingling in my hands
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have numbness or tingling in my feet
text
Code List
I have numbness or tingling in my feet
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have joint pain or muscle cramps
text
Code List
I have joint pain or muscle cramps
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I feel weak all over
text
Code List
I feel weak all over
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have trouble hearing
text
Code List
I have trouble hearing
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I get a ringing or buzzing in my ears
text
Code List
I get a ringing or buzzing in my ears
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have trouble buttoning buttons
text
Code List
I have trouble buttoning buttons
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have trouble feeling the shape of small objects when they are in my hand
text
Code List
I have trouble feeling the shape of small objects when they are in my hand
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item
I have trouble walking
text
Code List
I have trouble walking
CL Item
not at all (1)
CL Item
a little bit (2)
CL Item
somewhat (3)
CL Item
quite a bit (4)
CL Item
very much (5)
Item Group
Brief Pain Inventory
Item Group
Brief Pain Inventory
Brief Pain Inventory
Item
Brief Pain Inventory (Please rate your pain on the scale from 1 to 10 that best describes your pain at its worst on the average)
float
Brief Pain Inventory
Item
Brief Pain Inventory (Please rate your pain on the scale from 1 to 10 that best describes your pain at its worst right now)
float
painkillers and treatment
Item
What treatments or medications are you receiving for your pain?
text
pain relief
Item
In the last 24 hours how much relief have pain medications provided?
integer
Brief Pain Inventory
Item
Brief Pain Inventory (Please rate your pain on the scale from 1 to 10 that best describes your pain at its worst in the last 24 hours)
float
Item Group
Pain Interference
Item
Mark how during the past 24 hours pain has interfered with your:
text
Code List
Mark how during the past 24 hours pain has interfered with your:
CL Item
general activity (1)
CL Item
mood (2)
CL Item
walking ability (includes both work outside the home and housework) (3)
CL Item
normal work (4)
CL Item
relationships with other people (5)
CL Item
sleep (6)
CL Item
enjoyment of life (7)
Interference scale
Item
Interference scale
text

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