ID
37972
Beskrivning
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
Nyckelord
Versioner (1)
- 2019-09-03 2019-09-03 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
3 september 2019
DOI
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Licens
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
Beskrivning
Are there any non-serious adverse events to report?
Alias
- UMLS CUI-1
- C1518404
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1518404
Beskrivning
Non-Serious adverse Events
Alias
- UMLS CUI-1
- C1518404
Beskrivning
Non-Serious adverse Event
Datatyp
text
Alias
- UMLS CUI [1]
- C1518404
Beskrivning
Non-Serious adverse Event Onset Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2985916
- UMLS CUI [1,2]
- C1518404
Beskrivning
Non-Serious adverse Event End Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Beskrivning
(If died, STOP; go to SAE section and follow instructions)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Beskrivning
Non-Serious adverse Event Experience Course
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0750729
Beskrivning
Non-Serious adverse Event Common Toxicity Grade
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2826262
Beskrivning
Non-Serious adverse Event - Action Taken with Respect to investigational Drug
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2826626
Beskrivning
Non-Serious adverse Event - Relationship to Investigational Drug
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beskrivning
If yes, record details in Concomitant Medication section
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0087111
Beskrivning
Was patient withdrawn due to this specific AE?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Beskrivning
Serious Adverse Event #1
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Serious Adverse Event
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Person Reporting SAE:
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C1519255
Beskrivning
Serious Adverse Event Onset Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2985916
- UMLS CUI [1,2]
- C1519255
Beskrivning
Serious Adverse Event Onset Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449244
Beskrivning
Serious Adverse Event End Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
Beskrivning
Serious Adverse Event End Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1522314
Beskrivning
Mark all that apply
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0392360
Beskrivning
If other reason(s) for considering this an SAE, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beskrivning
Serious Adverse Event Outcome
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beskrivning
Serious Adverse Event - Experience Course
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0750729
Beskrivning
Serious Adverse Event - Common Toxicity Grade
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826262
Beskrivning
Serious Adverse Event - Action Taken with Respect to Investigational Drug
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826626
Beskrivning
Did the SAE abate?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3853704
Beskrivning
If study medication was interrupted, stopped, or dose reduced, was study Medication reintroduced (or dose decresed)?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1707811
Beskrivning
If study Medication was reintroduced, did SAE recur?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1707811
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0034897
Beskrivning
Serious Adverse Event - Relationship to Investigatinoal Drug
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
Beskrivning
Mark one
Datatyp
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
Beskrivning
If SAE is associated with Protocol design or procedures, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0184661
- UMLS CUI [1,3]
- C0332281
- UMLS CUI [1,4]
- C2348235
Beskrivning
If SAE ist associated with another condition, specify
Datatyp
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
Beskrivning
If SAE is associated with another Drug, specify
Datatyp
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
Beskrivning
If yes, record details in Concomitant Medication section
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0087111
Beskrivning
Was patient withdrawn due to this specific SAE?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1519255
Beskrivning
Please provide a brief narrative description of he SAE, attaching extra pages e.g., hospital discharge summary if necessary.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0947611
Beskrivning
Serious Adverse Event #1 - Relevant Laboratory Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0587081
Beskrivning
Laboratory Test
Datatyp
text
Alias
- UMLS CUI [1]
- C0022885
Beskrivning
Laboratory Test Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826641
Beskrivning
Laboratory Test Value
Datatyp
text
Alias
- UMLS CUI [1]
- C0587081
Beskrivning
Laboratory Test Units
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Beskrivning
Laboratory Test Normal Range
Datatyp
text
Alias
- UMLS CUI [1]
- C1096215
Beskrivning
Serious Adverse Event #1 - Signature
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2346576
Beskrivning
Confirming above data are accurate and complete.^
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2346576
Beskrivning
Investigator's Name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Investigator's Siganture Date Signed
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
Medical Monitor‘s Signature
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1708968
- UMLS CUI [1,2]
- C1519316
Beskrivning
Medical Monitor's Name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C1708968
Beskrivning
Medical Monitors Signature Date Signed
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1708968
- UMLS CUI [1,2]
- C1519316
- UMLS CUI [1,3]
- C0011008
Beskrivning
Prior and Concomitant Medications
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
Beskrivning
Prior and Concomitant Medications
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
Beskrivning
Line Number
Datatyp
integer
Alias
- UMLS CUI [1]
- C0449788
Beskrivning
If a combmation drug, use Trade name.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0592502
Beskrivning
Medication Dose
Datatyp
text
Alias
- UMLS CUI [1]
- C3174092
Beskrivning
Medication Units
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1519795
Beskrivning
Medication Route
Datatyp
text
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
Medication Frequency
Datatyp
text
Alias
- UMLS CUI [1]
- C3476109
Beskrivning
Medication Indication
Datatyp
text
Alias
- UMLS CUI [1]
- C2826696
- UMLS CUI [2,1]
- C3146298
- UMLS CUI [2,2]
- C0013227
Beskrivning
Medication prior to study medication
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826257
- UMLS CUI [2]
- C0304229
Beskrivning
Concomitant Medication
Datatyp
integer
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
Medication Start Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beskrivning
Medication End Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beskrivning
OR Ongoing at end of study
Datatyp
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])