ID

42277

Beskrivning

Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Nyckelord

Versioner (1)
  1. 2021-04-28 2021-04-28 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

28 april 2021

DOI

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Creative Commons BY 4.0
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Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410)

Engelsk

Module 2 - Regimen 1 and Regimen 2: Days 1 - 5 - Weight/ Body Surface Area; Topotecan Study Medication Record; Pre-Cisplatin Hydration Record; Cisplatin Study Medication Record; Post-Cisplatin Hydration Record; Post-Cisplatin Dosing; Etoposide Study Medication Record; Vital Signs

1 Formulär  
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Centre Number
Beskrivning

Centre Number

Datatyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient Number
Beskrivning

Patient Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Patient Initials
Beskrivning

Patient Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Day 1 Visit Date
Beskrivning

Day 1 Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Course Delay (Regimen 1, Regimen 2)
Beskrivning

Course Delay (Regimen 1, Regimen 2)

Alias
UMLS CUI-1
C0750729
UMLS CUI-2
C1299700
Was course delayed?
Beskrivning

Was course delayed?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C1299700
Reason for Delay
Beskrivning

If applicable, mark more than one box below

Datatyp

integer

Alias
UMLS CUI [1]
C1298642
Specify other reason for delay
Beskrivning

Specify other reason for delay

Datatyp

text

Alias
UMLS CUI [1,1]
C1298642
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Weight/Body Surface Area (Regimen 1, Regimen 2)
Beskrivning

Weight/Body Surface Area (Regimen 1, Regimen 2)

Alias
UMLS CUI-1
C0005910
UMLS CUI-2
C0005902
Weight
Beskrivning

Weight

Datatyp

float

Alias
UMLS CUI [1]
C0005910
Weight in kg or ibs
Beskrivning

Weight in kg or ibs

Datatyp

integer

Alias
UMLS CUI [1]
C0005910
Body Surface Area
Beskrivning

Body Surface Area

Datatyp

float

Måttenheter
  • m^2
Alias
UMLS CUI [1]
C0005902
m^2
Topotecan Study Medication Record (Regimen 1, Regimen 2)
Beskrivning

Topotecan Study Medication Record (Regimen 1, Regimen 2)

Alias
UMLS CUI-1
C0146224
UMLS CUI-2
C2734539
UMLS CUI-3
C0008972
Day (Topotecan)
Beskrivning

Day (Topotecan)

Datatyp

integer

Alias
UMLS CUI [1]
C0439228
UMLS CUI [2]
C0146224
Scheduled Daily Dose for this Infusion (Topotecan)
Beskrivning

Scheduled Daily Dose for this Infusion (Topotecan)

Datatyp

float

Måttenheter
  • mg/m^2
Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0205539
UMLS CUI [2]
C0574032
UMLS CUI [3]
C0146224
mg/m^2
Total Daily Dose for this Infusion (Topotecan)
Beskrivning

Total Daily Dose for this Infusion (Topotecan)

Datatyp

float

Måttenheter
  • mg
Alias
UMLS CUI [1]
C2348070
UMLS CUI [2]
C0574032
UMLS CUI [3]
C0146224
mg
Infusion Start Date (Topotecan)
Beskrivning

Infusion Start Date (Topotecan)

Datatyp

date

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0808070
UMLS CUI [2]
C0146224
Infusion Start Time (Topotecan)
Beskrivning

Infusion Start Time (Topotecan)

Datatyp

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1301880
UMLS CUI [2]
C0146224
Infusion Stop Date (Topotecan)
Beskrivning

Infusion Stop Date (Topotecan)

Datatyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0574032
UMLS CUI [2]
C0146224
Infusion Stop Time (Topotecan)
Beskrivning

Infusion Stop Time (Topotecan)

Datatyp

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0574032
UMLS CUI [2]
C0146224
Topotecan Study Medication Record (Regimen 1, Regimen 2)
Beskrivning

Topotecan Study Medication Record (Regimen 1, Regimen 2)

Alias
UMLS CUI-1
C0146224
UMLS CUI-2
C2734539
UMLS CUI-3
C0008972
Was topotecan dose reduced compared to previous course?
Beskrivning

Was topotecan dose reduced compared to previous course?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C1707814
Reason for dose reduced
Beskrivning

If applicable, mark more than one box below

Datatyp

integer

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C3146298
Specify other reason for dose reduced
Beskrivning

Specify other reason for dose reduced

Datatyp

text

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C3146298
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Day 5 Pre-Cisplatin Hydration Record (Regimen 1)
Beskrivning

Day 5 Pre-Cisplatin Hydration Record (Regimen 1)

Alias
UMLS CUI-1
C0008838
UMLS CUI-2
C1321013
UMLS CUI-3
C0332152
Hydration regimen (Pre-Cisplatin)
Beskrivning

Hydration regimen (Pre-Cisplatin)

Datatyp

text

Alias
UMLS CUI [1,1]
C1321013
UMLS CUI [1,2]
C1276413
UMLS CUI [2,1]
C0008838
UMLS CUI [2,2]
C0332152
Date of Infusion (Pre-Cisplatin)
Beskrivning

Date of Infusion (Pre-Cisplatin)

Datatyp

date

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0008838
UMLS CUI [2,2]
C0332152
Time Infusion Started (Pre-Cisplatin)
Beskrivning

Time Infusion Started (Pre-Cisplatin)

Datatyp

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1301880
UMLS CUI [2,1]
C0008838
UMLS CUI [2,2]
C0332152
Total Administered (Pre-Cisplatin)
Beskrivning

Total Administered (Pre-Cisplatin)

Datatyp

float

Måttenheter
  • mL
Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0439810
UMLS CUI [2,1]
C0008838
UMLS CUI [2,2]
C0332152
mL
Time Infusion Ended (Pre-Cisplatin)
Beskrivning

Time Infusion Ended (Pre-Cisplatin)

Datatyp

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1522314
UMLS CUI [2,1]
C0008838
UMLS CUI [2,2]
C0332152
Day 5 Cisplatin Study Medication Record (Regimen 1)
Beskrivning

Day 5 Cisplatin Study Medication Record (Regimen 1)

Alias
UMLS CUI-1
C0008838
UMLS CUI-2
C0304229
UMLS CUI-3
C2734539
Scheduled Dose For This Infusion (Cisplatin)
Beskrivning

Scheduled Dose For This Infusion (Cisplatin)

Datatyp

float

Måttenheter
  • mg/m^2
Alias
UMLS CUI [1]
C0574032
UMLS CUI [2,1]
C3174092
UMLS CUI [2,2]
C0205539
UMLS CUI [3]
C0008838
mg/m^2
Date Infusion Started (Cisplatin)
Beskrivning

Date Infusion Started (Cisplatin)

Datatyp

date

Alias
UMLS CUI [1,1]
C3173309
UMLS CUI [1,2]
C0574032
UMLS CUI [2]
C0008838
Time Infusion Started (Cisplatin)
Beskrivning

Time Infusion Started (Cisplatin)

Datatyp

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1301880
UMLS CUI [2]
C0008838
Total Administered (Cisplatin)
Beskrivning

Total Administered (Cisplatin)

Datatyp

float

Måttenheter
  • mg
Alias
UMLS CUI [1,1]
C1521801
UMLS CUI [1,2]
C0439810
UMLS CUI [2]
C0008838
mg
Date Infusion Ended (Cisplatin)
Beskrivning

Date Infusion Ended (Cisplatin)

Datatyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0574032
UMLS CUI [2]
C0008838
Time Infusion Ended (Cisplatin)
Beskrivning

Time Infusion Ended (Cisplatin)

Datatyp

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0574032
UMLS CUI [2]
C0008838
Cisplatin Study Medication Record
Beskrivning

Cisplatin Study Medication Record

Alias
UMLS CUI-1
C0008838
UMLS CUI-2
C2734539
UMLS CUI-3
C0008972
Was cisplatin dose reduced compared to previous course?
Beskrivning

Was cisplatin dose reduced compared to previous course?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008838
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C1707814
Reason for dose reduced
Beskrivning

If applicable, mark more than one box below

Datatyp

integer

Alias
UMLS CUI [1,1]
C0008838
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C3146298
Specify other reason for dose reduced
Beskrivning

Specify other reason for dose reduced

Datatyp

text

Alias
UMLS CUI [1,1]
C0008838
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C3146298
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Day 5 Post-Cisplatin Hydration Record (Regimen 1)
Beskrivning

Day 5 Post-Cisplatin Hydration Record (Regimen 1)

Alias
UMLS CUI-1
C0008838
UMLS CUI-2
C1321013
UMLS CUI-3
C0231290
Hydration regimen (Post-Cisplatin)
Beskrivning

Hydration regimen (Post-Cisplatin)

Datatyp

text

Alias
UMLS CUI [1]
C1321013
UMLS CUI [2,1]
C0008838
UMLS CUI [2,2]
C0231290
Date of Infusion (Post-Cisplatin)
Beskrivning

Date of Infusion (Post-Cisplatin)

Datatyp

date

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0008838
UMLS CUI [2,2]
C0231290
Time Infusion Started (Post-Cisplatin)
Beskrivning

Time Infusion Started (Post-Cisplatin)

Datatyp

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1301880
UMLS CUI [2,1]
C0008838
UMLS CUI [2,2]
C0231290
Total Administered (Post-Cisplatin)
Beskrivning

Total Administered (Post-Cisplatin)

Datatyp

float

Måttenheter
  • mL
Alias
UMLS CUI [1,1]
C1521801
UMLS CUI [1,2]
C0439810
UMLS CUI [2,1]
C0008838
UMLS CUI [2,2]
C0231290
mL
Time Infusion Ended (Post-Cisplatin)
Beskrivning

Time Infusion Ended (Post-Cisplatin)

Datatyp

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0574032
UMLS CUI [2,1]
C0008838
UMLS CUI [2,2]
C0231290
Day 5 Vital Signs, Post-Cisplatin Dosing (Regimen 1)
Beskrivning

Day 5 Vital Signs, Post-Cisplatin Dosing (Regimen 1)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0008838
UMLS CUI-3
C0439568
Date and time vital signs performed (Post-Cisplatin)
Beskrivning

Date and time vital signs performed (Post-Cisplatin)

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
UMLS CUI [2,1]
C0008838
UMLS CUI [2,2]
C0231290
Temperature (Post-Cisplatin)
Beskrivning

Temperature (Post-Cisplatin)

Datatyp

float

Alias
UMLS CUI [1]
C0005903
UMLS CUI [2,1]
C0008838
UMLS CUI [2,2]
C0231290
Temperature (Post-Cisplatin)
Beskrivning

Temperature (Post-Cisplatin)

Datatyp

integer

Alias
UMLS CUI [1]
C0005903
UMLS CUI [2,1]
C0008838
UMLS CUI [2,2]
C0231290
Temperature measurement site (Post-Cisplatin)
Beskrivning

Temperature measurement site (Post-Cisplatin)

Datatyp

integer

Alias
UMLS CUI [1]
C0489453
UMLS CUI [2,1]
C0008838
UMLS CUI [2,2]
C0231290
Sitting Systolic Blood Pressure (Post-Cisplatin)
Beskrivning

After 5 Minutes Sitting

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
UMLS CUI [2,1]
C0008838
UMLS CUI [2,2]
C0231290
mm[Hg]
Diastolic Sitting Blood Pressure (Post-Cisplatin)
Beskrivning

After 5 Minutes Sitting

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
UMLS CUI [2,1]
C0008838
UMLS CUI [2,2]
C0231290
mm[Hg]
Pulse (Post-Cisplatin)
Beskrivning

After 5 Minutes Sitting

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0232117
UMLS CUI [2,1]
C0008838
UMLS CUI [2,2]
C0231290
beats/min
Etoposide Study Medication Record (Regimen 2)
Beskrivning

Etoposide Study Medication Record (Regimen 2)

Alias
UMLS CUI-1
C0015133
UMLS CUI-2
C0304229
UMLS CUI-3
C2734539
Day (Etoposide)
Beskrivning

Day (Etoposide)

Datatyp

integer

Alias
UMLS CUI [1]
C0439228
UMLS CUI [2]
C0015133
Scheduled Daily Dose for this Infusion (Etoposide)
Beskrivning

Scheduled Daily Dose for this Infusion (Etoposide)

Datatyp

float

Måttenheter
  • mg/m^2
Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0205539
UMLS CUI [2]
C0574032
UMLS CUI [3]
C0015133
mg/m^2
Total Daily Dose for this Infusion (Etoposide)
Beskrivning

Total Daily Dose for this Infusion (Etoposide)

Datatyp

float

Måttenheter
  • mg
Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0574032
UMLS CUI [2]
C0015133
mg
Infusion Start Date (Etoposide)
Beskrivning

Infusion Start Date (Etoposide)

Datatyp

date

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0808070
UMLS CUI [2]
C0015133
Infusion Start Time (Etoposide)
Beskrivning

Infusion Start Time (Etoposide)

Datatyp

time

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C1301880
UMLS CUI [2]
C0015133
Infusion Stop Date (Etoposide)
Beskrivning

Infusion Stop Date (Etoposide)

Datatyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0574032
UMLS CUI [2]
C0015133
Infusion Stop Time (Etoposide)
Beskrivning

Infusion Stop Time (Etoposide)

Datatyp

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0574032
UMLS CUI [2]
C0015133
Etoposide Study Medication Record
Beskrivning

Etoposide Study Medication Record

Alias
UMLS CUI-1
C0015133
UMLS CUI-2
C2734539
UMLS CUI-3
C0008972
Was etoposide dose reduced compared to previous course?
Beskrivning

Was etoposide dose reduced compared to previous course?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015133
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C1707814
Reason for dose reduced
Beskrivning

If applicable, mark more than one box below

Datatyp

integer

Alias
UMLS CUI [1,1]
C0015133
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C3146298
Specify other reason for dose reduced
Beskrivning

Specify other reason for dose reduced

Datatyp

text

Alias
UMLS CUI [1,1]
C0015133
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C3146298
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Day 5 Vital Signs, Post-Etoposide Dosing (Regimen 2)
Beskrivning

Day 5 Vital Signs, Post-Etoposide Dosing (Regimen 2)

Alias
UMLS CUI-1
C0015133
UMLS CUI-2
C0008838
UMLS CUI-3
C0439568
Date and time vital signs performed (Post-Etoposide)
Beskrivning

Date and time vital signs performed (Post-Etoposide)

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
UMLS CUI [2,1]
C0015133
UMLS CUI [2,2]
C0231290
Temperature (Post-Etoposide)
Beskrivning

Temperature (Post-Etoposide)

Datatyp

float

Alias
UMLS CUI [1]
C0005903
UMLS CUI [2,1]
C0015133
UMLS CUI [2,2]
C0231290
Temperature (Post-Etoposide)
Beskrivning

Temperature (Post-Etoposide)

Datatyp

integer

Alias
UMLS CUI [1]
C0005903
UMLS CUI [2,1]
C0015133
UMLS CUI [2,2]
C0231290
Temperature site (Post-Etoposide)
Beskrivning

Temperature site (Post-Etoposide)

Datatyp

integer

Alias
UMLS CUI [1]
C0489453
UMLS CUI [2,1]
C0015133
UMLS CUI [2,2]
C0231290
Sitting Systolic Blood Pressure (Post-Etoposide)
Beskrivning

After 5 Minutes Sitting

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
UMLS CUI [2,1]
C0015133
UMLS CUI [2,2]
C0231290
mm[Hg]
Diastolic Sitting Blood Pressure (Post-Etoposide)
Beskrivning

After 5 Minutes Sitting

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
UMLS CUI [2,1]
C0015133
UMLS CUI [2,2]
C0231290
mm[Hg]
Pulse (Post-Etoposide)
Beskrivning

After 5 Minutes Sitting

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0232117
UMLS CUI [2,1]
C0015133
UMLS CUI [2,2]
C0231290
beats/min
Tillbaka till toppen

Similar models

Module 2 - Regimen 1 and Regimen 2: Days 1 - 5 - Weight/ Body Surface Area; Topotecan Study Medication Record; Pre-Cisplatin Hydration Record; Cisplatin Study Medication Record; Post-Cisplatin Hydration Record; Post-Cisplatin Dosing; Etoposide Study Medication Record; Vital Signs

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Day 1 Visit Date
Item
Day 1 Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Course Delay (Regimen 1, Regimen 2)
C0750729 (UMLS CUI-1)
C1299700 (UMLS CUI-2)
Was course delayed?
Item
Was course delayed?
boolean
C0750729 (UMLS CUI [1,1])
C1299700 (UMLS CUI [1,2])
Item
Reason for Delay
integer
C1298642 (UMLS CUI [1])
Reason for Delay
Code List
Reason for Delay
CL Item
Haematology (1)
CL Item
Non-Haematology AE (2)
CL Item
Other, specify (3)
Specify other reason for delay
Item
Specify other reason for delay
text
C1298642 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Weight/Body Surface Area (Regimen 1, Regimen 2)
C0005910 (UMLS CUI-1)
C0005902 (UMLS CUI-2)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item
Weight in kg or ibs
integer
C0005910 (UMLS CUI [1])
Weight in kg or ibs
Code List
Weight in kg or ibs
CL Item
kg (1)
CL Item
ibs (2)
Body Surface Area
Item
Body Surface Area
float
C0005902 (UMLS CUI [1])
Item Group
Topotecan Study Medication Record (Regimen 1, Regimen 2)
C0146224 (UMLS CUI-1)
C2734539 (UMLS CUI-2)
C0008972 (UMLS CUI-3)
Day (Topotecan)
Item
Day (Topotecan)
integer
C0439228 (UMLS CUI [1])
C0146224 (UMLS CUI [2])
Scheduled Daily Dose for this Infusion (Topotecan)
Item
Scheduled Daily Dose for this Infusion (Topotecan)
float
C2348070 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0574032 (UMLS CUI [2])
C0146224 (UMLS CUI [3])
Total Daily Dose for this Infusion (Topotecan)
Item
Total Daily Dose for this Infusion (Topotecan)
float
C2348070 (UMLS CUI [1])
C0574032 (UMLS CUI [2])
C0146224 (UMLS CUI [3])
Infusion Start Date (Topotecan)
Item
Infusion Start Date (Topotecan)
date
C0574032 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
Infusion Start Time (Topotecan)
Item
Infusion Start Time (Topotecan)
time
C0574032 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
Infusion Stop Date (Topotecan)
Item
Infusion Stop Date (Topotecan)
date
C0806020 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
Infusion Stop Time (Topotecan)
Item
Infusion Stop Time (Topotecan)
time
C1522314 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
Item Group
Topotecan Study Medication Record (Regimen 1, Regimen 2)
C0146224 (UMLS CUI-1)
C2734539 (UMLS CUI-2)
C0008972 (UMLS CUI-3)
Was topotecan dose reduced compared to previous course?
Item
Was topotecan dose reduced compared to previous course?
boolean
C0146224 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
Item
Reason for dose reduced
integer
C0146224 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
Reason for dose reduced
Code List
Reason for dose reduced
CL Item
Haematology (1)
CL Item
Non-Haematology AE (Record in the Adverse Experience section at the back of the previous module) (2)
CL Item
Other, specify (3)
Specify other reason for dose reduced
Item
Specify other reason for dose reduced
text
C0146224 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item Group
Day 5 Pre-Cisplatin Hydration Record (Regimen 1)
C0008838 (UMLS CUI-1)
C1321013 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
Hydration regimen (Pre-Cisplatin)
Item
Hydration regimen (Pre-Cisplatin)
text
C1321013 (UMLS CUI [1,1])
C1276413 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
Date of Infusion (Pre-Cisplatin)
Item
Date of Infusion (Pre-Cisplatin)
date
C0574032 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
Time Infusion Started (Pre-Cisplatin)
Item
Time Infusion Started (Pre-Cisplatin)
time
C0574032 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
Total Administered (Pre-Cisplatin)
Item
Total Administered (Pre-Cisplatin)
float
C1533734 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
Time Infusion Ended (Pre-Cisplatin)
Item
Time Infusion Ended (Pre-Cisplatin)
time
C0574032 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
Item Group
Day 5 Cisplatin Study Medication Record (Regimen 1)
C0008838 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C2734539 (UMLS CUI-3)
Scheduled Dose For This Infusion (Cisplatin)
Item
Scheduled Dose For This Infusion (Cisplatin)
float
C0574032 (UMLS CUI [1])
C3174092 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
C0008838 (UMLS CUI [3])
Date Infusion Started (Cisplatin)
Item
Date Infusion Started (Cisplatin)
date
C3173309 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2])
Time Infusion Started (Cisplatin)
Item
Time Infusion Started (Cisplatin)
time
C0574032 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2])
Total Administered (Cisplatin)
Item
Total Administered (Cisplatin)
float
C1521801 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2])
Date Infusion Ended (Cisplatin)
Item
Date Infusion Ended (Cisplatin)
date
C0806020 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2])
Time Infusion Ended (Cisplatin)
Item
Time Infusion Ended (Cisplatin)
time
C1522314 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2])
Item Group
Cisplatin Study Medication Record
C0008838 (UMLS CUI-1)
C2734539 (UMLS CUI-2)
C0008972 (UMLS CUI-3)
Was cisplatin dose reduced compared to previous course?
Item
Was cisplatin dose reduced compared to previous course?
boolean
C0008838 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
Item
Reason for dose reduced
integer
C0008838 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
Reason for dose reduced
Code List
Reason for dose reduced
CL Item
Haematology  (1)
CL Item
Non-Haematology AE (Record in the Adverse Experience section at the back of the previous module)  (2)
CL Item
Other, specify (3)
Specify other reason for dose reduced
Item
Specify other reason for dose reduced
text
C0008838 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item Group
Day 5 Post-Cisplatin Hydration Record (Regimen 1)
C0008838 (UMLS CUI-1)
C1321013 (UMLS CUI-2)
C0231290 (UMLS CUI-3)
Hydration regimen (Post-Cisplatin)
Item
Hydration regimen (Post-Cisplatin)
text
C1321013 (UMLS CUI [1])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Date of Infusion (Post-Cisplatin)
Item
Date of Infusion (Post-Cisplatin)
date
C0574032 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Time Infusion Started (Post-Cisplatin)
Item
Time Infusion Started (Post-Cisplatin)
time
C0574032 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Total Administered (Post-Cisplatin)
Item
Total Administered (Post-Cisplatin)
float
C1521801 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Time Infusion Ended (Post-Cisplatin)
Item
Time Infusion Ended (Post-Cisplatin)
time
C1522314 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Item Group
Day 5 Vital Signs, Post-Cisplatin Dosing (Regimen 1)
C0518766 (UMLS CUI-1)
C0008838 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
Date and time vital signs performed (Post-Cisplatin)
Item
Date and time vital signs performed (Post-Cisplatin)
datetime
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Temperature (Post-Cisplatin)
Item
Temperature (Post-Cisplatin)
float
C0005903 (UMLS CUI [1])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Item
Temperature (Post-Cisplatin)
integer
C0005903 (UMLS CUI [1])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Temperature
Code List
Temperature (Post-Cisplatin)
CL Item
°C (1)
CL Item
°F (2)
Item
Temperature measurement site (Post-Cisplatin)
integer
C0489453 (UMLS CUI [1])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Temperature site
Code List
Temperature measurement site (Post-Cisplatin)
CL Item
Oral (1)
CL Item
Axillary (2)
CL Item
Tympanic (3)
CL Item
Rectal (4)
Sitting Systolic Blood Pressure (Post-Cisplatin)
Item
Sitting Systolic Blood Pressure (Post-Cisplatin)
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Diastolic Sitting Blood Pressure (Post-Cisplatin)
Item
Diastolic Sitting Blood Pressure (Post-Cisplatin)
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Pulse (Post-Cisplatin)
Item
Pulse (Post-Cisplatin)
integer
C0232117 (UMLS CUI [1])
C0008838 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Item Group
Etoposide Study Medication Record (Regimen 2)
C0015133 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
C2734539 (UMLS CUI-3)
Day (Etoposide)
Item
Day (Etoposide)
integer
C0439228 (UMLS CUI [1])
C0015133 (UMLS CUI [2])
Scheduled Daily Dose for this Infusion (Etoposide)
Item
Scheduled Daily Dose for this Infusion (Etoposide)
float
C2348070 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0574032 (UMLS CUI [2])
C0015133 (UMLS CUI [3])
Total Daily Dose for this Infusion (Etoposide)
Item
Total Daily Dose for this Infusion (Etoposide)
float
C2348070 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0015133 (UMLS CUI [2])
Infusion Start Date (Etoposide)
Item
Infusion Start Date (Etoposide)
date
C0574032 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0015133 (UMLS CUI [2])
Infusion Start Time (Etoposide)
Item
Infusion Start Time (Etoposide)
time
C0574032 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C0015133 (UMLS CUI [2])
Infusion Stop Date (Etoposide)
Item
Infusion Stop Date (Etoposide)
date
C0806020 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0015133 (UMLS CUI [2])
Infusion Stop Time (Etoposide)
Item
Infusion Stop Time (Etoposide)
time
C1522314 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0015133 (UMLS CUI [2])
Item Group
Etoposide Study Medication Record
C0015133 (UMLS CUI-1)
C2734539 (UMLS CUI-2)
C0008972 (UMLS CUI-3)
Was etoposide dose reduced compared to previous course?
Item
Was etoposide dose reduced compared to previous course?
boolean
C0015133 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,3])
Item
Reason for dose reduced
integer
C0015133 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
Reason for dose reduced
Code List
Reason for dose reduced
CL Item
Haematology  (1)
CL Item
Non-Haematology AE (Record in the Adverse Experience section at the back of the previous module)  (2)
CL Item
Other, specify (3)
Specify other reason for dose reduced
Item
Specify other reason for dose reduced
text
C0015133 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item Group
Day 5 Vital Signs, Post-Etoposide Dosing (Regimen 2)
C0015133 (UMLS CUI-1)
C0008838 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
Date and time vital signs performed (Post-Etoposide)
Item
Date and time vital signs performed (Post-Etoposide)
datetime
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0015133 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Temperature (Post-Etoposide)
Item
Temperature (Post-Etoposide)
float
C0005903 (UMLS CUI [1])
C0015133 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Item
Temperature (Post-Etoposide)
integer
C0005903 (UMLS CUI [1])
C0015133 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Temperature
Code List
Temperature (Post-Etoposide)
CL Item
°C  (1)
CL Item
°F (2)
Item
Temperature site (Post-Etoposide)
integer
C0489453 (UMLS CUI [1])
C0015133 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Temperature site
Code List
Temperature site (Post-Etoposide)
CL Item
Oral  (1)
CL Item
Axillary  (2)
CL Item
Tympanic  (3)
CL Item
Rectal (4)
Sitting Systolic Blood Pressure (Post-Etoposide)
Item
Sitting Systolic Blood Pressure (Post-Etoposide)
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C0015133 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Diastolic Sitting Blood Pressure (Post-Etoposide)
Item
Diastolic Sitting Blood Pressure (Post-Etoposide)
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C0015133 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
Pulse (Post-Etoposide)
Item
Pulse (Post-Etoposide)
integer
C0232117 (UMLS CUI [1])
C0015133 (UMLS CUI [2,1])
C0231290 (UMLS CUI [2,2])
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