ID
37972
Description
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
Keywords
Versions (1)
- 9/3/19 9/3/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 3, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308
Adverse Events; Serious Adverse Event; Prior and Concomitant Medications
Description
Are there any non-serious adverse events to report?
Alias
- UMLS CUI-1
- C1518404
Description
If yes, record any adverse events (using standard medical terminology) observed or elicited by the following direct question to patient: Do you feel different in any way since starting the treatment or since the last visit? Provide the diagnosis, not symptoms, where possible. Record only one adverse event per column.
Data type
boolean
Alias
- UMLS CUI [1]
- C1518404
Description
Non-Serious adverse Events
Alias
- UMLS CUI-1
- C1518404
Description
Non-Serious adverse Event
Data type
text
Alias
- UMLS CUI [1]
- C1518404
Description
Non-Serious adverse Event Onset Date
Data type
date
Alias
- UMLS CUI [1,1]
- C2985916
- UMLS CUI [1,2]
- C1518404
Description
Non-Serious adverse Event End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Description
(If died, STOP; go to SAE section and follow instructions)
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Description
Non-Serious adverse Event Experience Course
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0750729
Description
Non-Serious adverse Event Common Toxicity Grade
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2826262
Description
Non-Serious adverse Event - Action Taken with Respect to investigational Drug
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2826626
Description
Non-Serious adverse Event - Relationship to Investigational Drug
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
If yes, record details in Concomitant Medication section
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0087111
Description
Was patient withdrawn due to this specific AE?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Description
Serious Adverse Event #1
Alias
- UMLS CUI-1
- C1519255
Description
Serious Adverse Event
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
Person Reporting SAE:
Data type
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C1519255
Description
Serious Adverse Event Onset Date
Data type
date
Alias
- UMLS CUI [1,1]
- C2985916
- UMLS CUI [1,2]
- C1519255
Description
Serious Adverse Event Onset Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449244
Description
Serious Adverse Event End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
Description
Serious Adverse Event End Time
Data type
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1522314
Description
Mark all that apply
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0392360
Description
If other reason(s) for considering this an SAE, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
Serious Adverse Event Outcome
Data type
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Description
Serious Adverse Event - Experience Course
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0750729
Description
Serious Adverse Event - Common Toxicity Grade
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826262
Description
Serious Adverse Event - Action Taken with Respect to Investigational Drug
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826626
Description
Did the SAE abate?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3853704
Description
If study medication was interrupted, stopped, or dose reduced, was study Medication reintroduced (or dose decresed)?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1707811
Description
If study Medication was reintroduced, did SAE recur?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1707811
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0034897
Description
Serious Adverse Event - Relationship to Investigatinoal Drug
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
Description
Mark one
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [2]
- C0445356
- UMLS CUI [3]
- C0332281
Description
If SAE is associated with Protocol design or procedures, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0184661
- UMLS CUI [1,3]
- C0332281
- UMLS CUI [1,4]
- C2348235
Description
If SAE ist associated with another condition, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0348080
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0332281
- UMLS CUI [1,5]
- C2348235
Description
If SAE is associated with another Drug, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0332281
- UMLS CUI [1,5]
- C2348235
Description
If yes, record details in Concomitant Medication section
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0087111
Description
Was patient withdrawn due to this specific SAE?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1519255
Description
Please provide a brief narrative description of he SAE, attaching extra pages e.g., hospital discharge summary if necessary.
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0947611
Description
Serious Adverse Event #1 - Relevant Laboratory Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0587081
Description
Laboratory Test
Data type
text
Alias
- UMLS CUI [1]
- C0022885
Description
Laboratory Test Date
Data type
date
Alias
- UMLS CUI [1]
- C2826641
Description
Laboratory Test Value
Data type
text
Alias
- UMLS CUI [1]
- C0587081
Description
Laboratory Test Units
Data type
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Description
Laboratory Test Normal Range
Data type
text
Alias
- UMLS CUI [1]
- C1096215
Description
Serious Adverse Event #1 - Signature
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2346576
Description
Confirming above data are accurate and complete.^
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2346576
Description
Investigator's Name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Investigator's Siganture Date Signed
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Medical Monitor‘s Signature
Data type
text
Alias
- UMLS CUI [1,1]
- C1708968
- UMLS CUI [1,2]
- C1519316
Description
Medical Monitor's Name
Data type
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C1708968
Description
Medical Monitors Signature Date Signed
Data type
date
Alias
- UMLS CUI [1,1]
- C1708968
- UMLS CUI [1,2]
- C1519316
- UMLS CUI [1,3]
- C0011008
Description
Prior and Concomitant Medications
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
Description
Prior and Concomitant Medications
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
Description
Line Number
Data type
integer
Alias
- UMLS CUI [1]
- C0449788
Description
If a combmation drug, use Trade name.
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0592502
Description
Medication Dose
Data type
text
Alias
- UMLS CUI [1]
- C3174092
Description
Medication Units
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1519795
Description
Medication Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Medication Frequency
Data type
text
Alias
- UMLS CUI [1]
- C3476109
Description
Medication Indication
Data type
text
Alias
- UMLS CUI [1]
- C2826696
- UMLS CUI [2,1]
- C3146298
- UMLS CUI [2,2]
- C0013227
Description
Medication prior to study medication
Data type
integer
Alias
- UMLS CUI [1]
- C2826257
- UMLS CUI [2]
- C0304229
Description
Concomitant Medication
Data type
integer
Alias
- UMLS CUI [1]
- C2347852
Description
Medication Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
Medication End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
OR Ongoing at end of study
Data type
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Similar models
Adverse Events; Serious Adverse Event; Prior and Concomitant Medications
C0600091 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C2826262 (UMLS CUI [1,2])
C2826626 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C2826262 (UMLS CUI [1,2])
C2826626 (UMLS CUI [1,2])
C3853704 (UMLS CUI [1,2])
C1707811 (UMLS CUI [1,2])
C1707811 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0445356 (UMLS CUI [2])
C0332281 (UMLS CUI [3])
C0184661 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0348080 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0332281 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0013227 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0332281 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0087111 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0587081 (UMLS CUI-2)
C0587081 (UMLS CUI [1,2])
C2346576 (UMLS CUI-2)
C2346576 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C0592502 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0304229 (UMLS CUI [2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])