ID

37963

Beschrijving

Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Trefwoorden

Versies (1)
  1. 02-09-19 02-09-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

2 september 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308

Engels

Course -- (Day 15 ) - Vital Signs; Hematology; Administration of Study Medications

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Center Number
Beschrijving

Center Number

Datatype

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Patient Number
Beschrijving

Patient Number

Datatype

text

Alias
UMLS CUI [1]
C1709561
Patient ID
Beschrijving

Patient ID

Datatype

text

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beschrijving

Date of Visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Visit not done
Beschrijving

Visit not done

Datatype

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1272696
Course Number
Beschrijving

Course Number

Datatype

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0750729
Day 15 Vital Signs
Beschrijving

Day 15 Vital Signs

Alias
UMLS CUI-1
C0518766
Systolic Blood Pressure
Beschrijving

Sitting after 5 mins.

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Beschrijving

Sitting after 5 mins.

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Pulse
Beschrijving

Sitting after 5 mins.

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Temperature
Beschrijving

Temperature

Datatype

float

Alias
UMLS CUI [1]
C0005903
Temperature Unit
Beschrijving

Temperature Unit

Datatype

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1519795
Hematology
Beschrijving

Hematology

Alias
UMLS CUI-1
C0474523
Hematology - Sample Date
Beschrijving

Hematology - Sample Date

Datatype

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0018941
Haematology - Laboratory Name
Beschrijving

Haematology - Laboratory Name

Datatype

text

Alias
UMLS CUI [1,1]
C3258037
UMLS CUI [1,2]
C0018941
Hematology
Beschrijving

Hematology

Alias
UMLS CUI-1
C0474523
Hematology Test
Beschrijving

Hematology Test

Datatype

integer

Alias
UMLS CUI [1]
C0018941
Hematology - No Result
Beschrijving

Hematology - No Result

Datatype

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1274040
Hematology - Value
Beschrijving

Hematology - Value

Datatype

text

Alias
UMLS CUI [1]
C0474523
Hematology - Value out of range and NOT clinically significant
Beschrijving

Hematology - Value out of range and NOT clinically significant

Datatype

integer

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0438215
UMLS CUI [1,3]
C2826293
Hematology - Value out of range and clinically significant
Beschrijving

Hematology - Value out of range and clinically significant

Datatype

integer

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0438215
UMLS CUI [1,3]
C2826293
Day 15 Administration of Study Medications
Beschrijving

Day 15 Administration of Study Medications

Alias
UMLS CUI-1
C3469597
UMLS CUI-2
C0304229
Were the study medications administered at Day 15?
Beschrijving

Were the study medications administered at Day 15?

Datatype

boolean

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C0304229
If study medication was not administered at Day 15, mark reason(s) why
Beschrijving

If study medication was not administered at Day 15, mark reason(s) why

Datatype

integer

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C0304229
UMLS CUI [2]
C2826287
If other reason for medication not administered, specify
Beschrijving

If other reason for medication not administered, specify

Datatype

text

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C0304229
UMLS CUI [2,1]
C2826287
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C2348235
Topotecan Administration
Beschrijving

Topotecan Administration

Alias
UMLS CUI-1
C3469597
UMLS CUI-2
C0146224
Was the topotecan dose reduced?
Beschrijving

Was the topotecan dose reduced?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C1707814
If topotecan dose was reduced, mark reason(s) dose was reduced
Beschrijving

If topotecan dose was reduced, mark reason(s) dose was reduced

Datatype

integer

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C3146298
If other reason topotecan dose was reduced, specify
Beschrijving

If other reason topotecan dose was reduced, specify

Datatype

text

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C3146298
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
Topotecan Dose Modification
Beschrijving

Topotecan Dose Modification

Datatype

integer

Alias
UMLS CUI [1,1]
C1707811
UMLS CUI [1,2]
C0146224
If other topotecan dose reduction, specify
Beschrijving

If other topotecan dose reduction, specify

Datatype

integer

Maateenheden
  • %
Alias
UMLS CUI [1,1]
C1707814
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
%
Topotecan scheduled dose
Beschrijving

Topotecan scheduled dose

Datatype

float

Maateenheden
  • mg/m2
Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C3174092
UMLS CUI [1,3]
C0205539
mg/m2
Total mg to be given (Topotecan)
Beschrijving

Total mg to be given (Topotecan)

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0439810
UMLS CUI [2]
C0146224
mg
Date Administered (Topotecan)
Beschrijving

Date Administered (Topotecan)

Datatype

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [2]
C0146224
Start Time (Topotecan)
Beschrijving

Start Time (Topotecan)

Datatype

time

Alias
UMLS CUI [1]
C1301880
UMLS CUI [2]
C0146224
Stop Time (Topotecan)
Beschrijving

Stop Time (Topotecan)

Datatype

time

Alias
UMLS CUI [1]
C1522314
UMLS CUI [2]
C0146224
Was complete dose given? (Topotecan)
Beschrijving

Was complete dose given? (Topotecan)

Datatype

boolean

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C0146224
If complete dose Topotecan was not given, provide actual mg given:
Beschrijving

If complete dose Topotecan was not given, provide actual mg given:

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C0146224
mg
Gemcitabine Administration
Beschrijving

Gemcitabine Administration

Alias
UMLS CUI-1
C3469597
UMLS CUI-2
C0045093
Was the gemcitabine dose reduced?
Beschrijving

Was the gemcitabine dose reduced?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0045093
UMLS CUI [1,2]
C1707814
If gemcitabine dose was reduced, mark reason(s) dose was reduced
Beschrijving

If gemcitabine dose was reduced, mark reason(s) dose was reduced

Datatype

integer

Alias
UMLS CUI [1,1]
C0045093
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C3146298
If other reason gemcitabine dose was reduced, specify
Beschrijving

If other reason gemcitabine dose was reduced, specify

Datatype

text

Alias
UMLS CUI [1,1]
C0045093
UMLS CUI [1,2]
C1707814
UMLS CUI [1,3]
C3146298
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
Gemcitabine Dose Modification
Beschrijving

Gemcitabine Dose Modification

Datatype

integer

Alias
UMLS CUI [1,1]
C1707811
UMLS CUI [1,2]
C0045093
If other gemcitabine dose reduction, specify
Beschrijving

If other gemcitabine dose reduction, specify

Datatype

integer

Maateenheden
  • %
Alias
UMLS CUI [1,1]
C1707814
UMLS CUI [1,2]
C0045093
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
%
Gemcitabine scheduled dose
Beschrijving

Gemcitabine scheduled dose

Datatype

float

Maateenheden
  • mg/m2
Alias
UMLS CUI [1,1]
C0045093
UMLS CUI [1,2]
C3174092
UMLS CUI [1,3]
C0205539
mg/m2
Total mg to be given (Gemicitabine)
Beschrijving

Total mg to be given (Gemicitabine)

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0439810
UMLS CUI [1,3]
C0045093
mg
Date Administered (Gemicitabine)
Beschrijving

Date Administered (Gemicitabine)

Datatype

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0045093
Start Time (Gemicitabine)
Beschrijving

Start Time (Gemicitabine)

Datatype

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0045093
Stop Time (Gemicitabine)
Beschrijving

Stop Time (Gemicitabine)

Datatype

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0045093
Was complete dose given? (Gemicitabine)
Beschrijving

Was complete dose given? (Gemicitabine)

Datatype

boolean

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0045093
If complete dose Gemcitabine was not given, provide actual mg given:
Beschrijving

If complete dose Gemcitabine was not given, provide actual mg given:

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0045093
mg
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Similar models

Course -- (Day 15 ) - Vital Signs; Hematology; Administration of Study Medications

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Center Number
Item
Center Number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1709561 (UMLS CUI [1])
Patient ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item
Visit not done
integer
C0545082 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Visit not done
Code List
Visit not done
CL Item
Visit Not Done (1)
Course Number
Item
Course Number
integer
C0237753 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Item Group
Day 15 Vital Signs
C0518766 (UMLS CUI-1)
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Temperature Unit
integer
C0005903 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Temperature Unit
Code List
Temperature Unit
CL Item
°C (1)
CL Item
°F (2)
Item Group
Hematology
C0474523 (UMLS CUI-1)
Hematology - Sample Date
Item
Hematology - Sample Date
date
C1302413 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Haematology - Laboratory Name
Item
Haematology - Laboratory Name
text
C3258037 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Item Group
Hematology
C0474523 (UMLS CUI-1)
Item
Hematology Test
integer
C0018941 (UMLS CUI [1])
Hematology Test
Code List
Hematology Test
CL Item
Hemoglobin  (1)
CL Item
Hematocrit  (2)
CL Item
RBC  (3)
CL Item
WBC  (4)
CL Item
Neutrophils  (5)
CL Item
Bands  (6)
CL Item
Lymphocytes  (7)
CL Item
Monocytes  (8)
CL Item
Eosinophils  (9)
CL Item
Basophils  (10)
CL Item
Platelets  (11)
CL Item
Granulocytes (12)
Item
Hematology - No Result
integer
C0018941 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Haematology - No Result
Code List
Hematology - No Result
CL Item
No Result (1)
Hematology - Value
Item
Hematology - Value
text
C0474523 (UMLS CUI [1])
Item
Hematology - Value out of range and NOT clinically significant
integer
C0474523 (UMLS CUI [1,1])
C0438215 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Haematology - Value out of range and NOT clinically significant
Code List
Hematology - Value out of range and NOT clinically significant
CL Item
Value out of range and NOT clinically significant (2)
Item
Hematology - Value out of range and clinically significant
integer
C0474523 (UMLS CUI [1,1])
C0438215 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Haematology - Value out of range and clinically significant
Code List
Hematology - Value out of range and clinically significant
CL Item
Value out of range and clinically significant (3)
Item Group
Day 15 Administration of Study Medications
C3469597 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Were the study medications administered at Day 15?
Item
Were the study medications administered at Day 15?
boolean
C3469597 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item
If study medication was not administered at Day 15, mark reason(s) why
integer
C3469597 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2826287 (UMLS CUI [2])
If study medication was not administered at Day 8, mark reason(s) why
Code List
If study medication was not administered at Day 15, mark reason(s) why
CL Item
Hematology (1)
CL Item
Non-Hematology (2)
CL Item
Other, specify (3)
If other reason for medication not administered, specify
Item
If other reason for medication not administered, specify
text
C3469597 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2826287 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
Item Group
Topotecan Administration
C3469597 (UMLS CUI-1)
C0146224 (UMLS CUI-2)
Was the topotecan dose reduced?
Item
Was the topotecan dose reduced?
boolean
C0146224 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
Item
If topotecan dose was reduced, mark reason(s) dose was reduced
integer
C0146224 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
If topotecan dose was reduced, mark reason(s) dose was reduced
Code List
If topotecan dose was reduced, mark reason(s) dose was reduced
CL Item
Hematology (1)
CL Item
Non-Hematology, specify (2)
If other reason topotecan dose was reduced, specify
Item
If other reason topotecan dose was reduced, specify
text
C0146224 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item
Topotecan Dose Modification
integer
C1707811 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
Topotecan Dose Modification
Code List
Topotecan Dose Modification
CL Item
No change (2)
CL Item
25% reduction (3)
CL Item
50% reduction (4)
CL Item
Other, specify (5)
CL Item
Re-escalation (1)
If other topotecan dose reduction, specify
Item
If other topotecan dose reduction, specify
integer
C1707814 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Topotecan scheduled dose
Item
Topotecan scheduled dose
float
C0146224 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
Total mg to be given (Topotecan)
Item
Total mg to be given (Topotecan)
float
C0178602 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
Date Administered (Topotecan)
Item
Date Administered (Topotecan)
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
Start Time (Topotecan)
Item
Start Time (Topotecan)
time
C1301880 (UMLS CUI [1])
C0146224 (UMLS CUI [2])
Stop Time (Topotecan)
Item
Stop Time (Topotecan)
time
C1522314 (UMLS CUI [1])
C0146224 (UMLS CUI [2])
Was complete dose given? (Topotecan)
Item
Was complete dose given? (Topotecan)
boolean
C3174092 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
If complete dose Topotecan was not given, provide actual mg given:
Item
If complete dose Topotecan was not given, provide actual mg given:
float
C3174092 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
Item Group
Gemcitabine Administration
C3469597 (UMLS CUI-1)
C0045093 (UMLS CUI-2)
Was the gemcitabine dose reduced?
Item
Was the gemcitabine dose reduced?
boolean
C0045093 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
Item
If gemcitabine dose was reduced, mark reason(s) dose was reduced
integer
C0045093 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
If gemcitabine dose was reduced, mark reason(s) dose was reduced
Code List
If gemcitabine dose was reduced, mark reason(s) dose was reduced
CL Item
Hematology  (1)
CL Item
Non-Hematology, specify (2)
If other reason gemcitabine dose was reduced, specify
Item
If other reason gemcitabine dose was reduced, specify
text
C0045093 (UMLS CUI [1,1])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item
Gemcitabine Dose Modification
integer
C1707811 (UMLS CUI [1,1])
C0045093 (UMLS CUI [1,2])
Gemcitabine Dose Modification
Code List
Gemcitabine Dose Modification
CL Item
No change  (2)
CL Item
25% reduction  (3)
CL Item
50% reduction  (4)
CL Item
Other, specify (5)
CL Item
Re-escalation (1)
If other gemcitabine dose reduction, specify
Item
If other gemcitabine dose reduction, specify
integer
C1707814 (UMLS CUI [1,1])
C0045093 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Gemcitabine scheduled dose
Item
Gemcitabine scheduled dose
float
C0045093 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
Total mg to be given (Gemicitabine)
Item
Total mg to be given (Gemicitabine)
float
C0178602 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0045093 (UMLS CUI [1,3])
Date Administered (Gemicitabine)
Item
Date Administered (Gemicitabine)
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0045093 (UMLS CUI [1,3])
Start Time (Gemicitabine)
Item
Start Time (Gemicitabine)
time
C1301880 (UMLS CUI [1,1])
C0045093 (UMLS CUI [1,2])
Stop Time (Gemicitabine)
Item
Stop Time (Gemicitabine)
time
C1522314 (UMLS CUI [1,1])
C0045093 (UMLS CUI [1,2])
Was complete dose given? (Gemicitabine)
Item
Was complete dose given? (Gemicitabine)
boolean
C3174092 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0045093 (UMLS CUI [1,3])
If complete dose Gemcitabine was not given, provide actual mg given:
Item
If complete dose Gemcitabine was not given, provide actual mg given:
float
C3174092 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0045093 (UMLS CUI [1,3])
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