ID

37914

Beschreibung

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

Stichworte

Versionen (1)
  1. 30.08.19 30.08.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

30. August 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

  • Neueste
  • Älteste
  • Beliebt
  • Neueste
    • Neueste
    • Älteste
    • Beliebt

Keine Kommentare

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308

Englisch

Course 2 (Day 1) - Eligibility; Vital Signs; Administration of Study Medications

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Center Number
Beschreibung

Center Number

Datentyp

text

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

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C1709561
Patient ID
Beschreibung

Patient ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Visit not done
Beschreibung

Visit not done

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1272696
Eligibility
Beschreibung

Eligibility

Alias
UMLS CUI-1
C0013893
Was this course delayed?
Beschreibung

Was this course delayed?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C0205421
If course was delayed, reason for delay
Beschreibung

If course was delayed, reason for delay

Datentyp

integer

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C0205421
UMLS CUI [1,3]
C0392360
If other reason for course delay, specify
Beschreibung

If other reason for course delay, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C0205421
UMLS CUI [1,3]
C0392360
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
Is the patient eligible to continue in the study?
Beschreibung

Is the patient eligible to continue in the study?

Datentyp

boolean

Alias
UMLS CUI [1]
C1302261
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Systolic Blood Pressure
Beschreibung

Sitting after 5 mins.

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Beschreibung

Sitting after 5 mins.

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Pulse
Beschreibung

Sitting after 5 mins.

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Temperature
Beschreibung

Temperature

Datentyp

float

Alias
UMLS CUI [1]
C0005903
Temperature Unit
Beschreibung

Temperature Unit

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1519795
Weight
Beschreibung

Light clothes and shoes off. Round to the nearest kg ob Ib.

Datentyp

integer

Alias
UMLS CUI [1]
C0005910
Weight Unit
Beschreibung

Weight Unit

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0439148
Body Surface Area
Beschreibung

Body Surface Area

Datentyp

float

Maßeinheiten
  • m2
Alias
UMLS CUI [1]
C0005902
m2
Administration of Study Medications
Beschreibung

Administration of Study Medications

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

Were the study medications administered at Day 1?

Datentyp

boolean

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

If study medication was not administered at Day 1, mark reason(s) why

Datentyp

integer

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

If other reason for medication not administered, specify

Datentyp

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
Beschreibung

Topotecan Administration

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

Was the topotecan dose reduced?

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

If other reason topotecan dose was reduced, specify

Datentyp

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
Beschreibung

Topotecan Dose Modification

Datentyp

integer

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

If other topotecan dose reduction, specify

Datentyp

integer

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

Topotecan scheduled dose

Datentyp

float

Maßeinheiten
  • 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)
Beschreibung

Total mg to be given (Topotecan)

Datentyp

float

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

Date Administered (Topotecan)

Datentyp

date

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

Start Time (Topotecan)

Datentyp

time

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

Stop Time (Topotecan)

Datentyp

time

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

Was complete dose given? (Topotecan)

Datentyp

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:
Beschreibung

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

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C0146224
mg
Gemcitabine Administration
Beschreibung

Gemcitabine Administration

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

Was the gemcitabine dose reduced?

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

If other reason gemcitabine dose was reduced, specify

Datentyp

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
Beschreibung

Gemcitabine Dose Modification

Datentyp

integer

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

If other gemcitabine dose reduction, specify

Datentyp

integer

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

Gemcitabine scheduled dose

Datentyp

float

Maßeinheiten
  • 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)
Beschreibung

Total mg to be given (Gemicitabine)

Datentyp

float

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

Date Administered (Gemicitabine)

Datentyp

date

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

Start Time (Gemicitabine)

Datentyp

time

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

Stop Time (Gemicitabine)

Datentyp

time

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

Was complete dose given? (Gemicitabine)

Datentyp

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:
Beschreibung

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

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0045093
mg
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Course 2 (Day 1) - Eligibility; Vital Signs; Administration of Study Medications

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
Item Group
Eligibility
C0013893 (UMLS CUI-1)
Was this course delayed?
Item
Was this course delayed?
boolean
C0750729 (UMLS CUI [1,1])
C0205421 (UMLS CUI [1,2])
Item
If course was delayed, reason for delay
integer
C0750729 (UMLS CUI [1,1])
C0205421 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
If course was delayed, reason for delay
Code List
If course was delayed, reason for delay
CL Item
Hemoglobin < 9.0 g/dL [90g/L] (1)
CL Item
Neutrophils < 1000 cells/mm3 [< 1.0 x 10*9/L] (2)
CL Item
Platelets < 100,000/mm3 [< 100.0 x 10*9/L] (3)
CL Item
Clinically significant non-hematologic drug related toxicity (4)
CL Item
Other, specify (5)
If other reason for course delay, specify
Item
If other reason for course delay, specify
text
C0750729 (UMLS CUI [1,1])
C0205421 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Is the patient eligible to continue in the study?
Item
Is the patient eligible to continue in the study?
boolean
C1302261 (UMLS CUI [1])
Item Group
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)
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Item
Weight Unit
integer
C0005910 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Weight Unit
Code List
Weight Unit
CL Item
kg (1)
CL Item
Ib (2)
Body Surface Area
Item
Body Surface Area
float
C0005902 (UMLS CUI [1])
Item Group
Administration of Study Medications
C3469597 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Were the study medications administered at Day 1?
Item
Were the study medications administered at Day 1?
boolean
C3469597 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item
If study medication was not administered at Day 1, 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 1, 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])
Zum Seitenanfang zurückkehren 

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video