ID
37972
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)
- 03-09-19 03-09-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
3 september 2019
DOI
Voor een aanvraag inloggen.
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
Adverse Events; Serious Adverse Event; Prior and Concomitant Medications
Beschrijving
Are there any non-serious adverse events to report?
Alias
- UMLS CUI-1
- C1518404
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1]
- C1518404
Beschrijving
Non-Serious adverse Events
Alias
- UMLS CUI-1
- C1518404
Beschrijving
Non-Serious adverse Event
Datatype
text
Alias
- UMLS CUI [1]
- C1518404
Beschrijving
Non-Serious adverse Event Onset Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2985916
- UMLS CUI [1,2]
- C1518404
Beschrijving
Non-Serious adverse Event End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Beschrijving
(If died, STOP; go to SAE section and follow instructions)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Beschrijving
Non-Serious adverse Event Experience Course
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0750729
Beschrijving
Non-Serious adverse Event Common Toxicity Grade
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2826262
Beschrijving
Non-Serious adverse Event - Action Taken with Respect to investigational Drug
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2826626
Beschrijving
Non-Serious adverse Event - Relationship to Investigational Drug
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschrijving
If yes, record details in Concomitant Medication section
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0087111
Beschrijving
Was patient withdrawn due to this specific AE?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Beschrijving
Serious Adverse Event #1
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Serious Adverse Event
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Person Reporting SAE:
Datatype
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C1519255
Beschrijving
Serious Adverse Event Onset Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2985916
- UMLS CUI [1,2]
- C1519255
Beschrijving
Serious Adverse Event Onset Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449244
Beschrijving
Serious Adverse Event End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
Beschrijving
Serious Adverse Event End Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1522314
Beschrijving
Mark all that apply
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0392360
Beschrijving
If other reason(s) for considering this an SAE, specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beschrijving
Serious Adverse Event Outcome
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beschrijving
Serious Adverse Event - Experience Course
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0750729
Beschrijving
Serious Adverse Event - Common Toxicity Grade
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826262
Beschrijving
Serious Adverse Event - Action Taken with Respect to Investigational Drug
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826626
Beschrijving
Did the SAE abate?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3853704
Beschrijving
If study medication was interrupted, stopped, or dose reduced, was study Medication reintroduced (or dose decresed)?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1707811
Beschrijving
If study Medication was reintroduced, did SAE recur?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1707811
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0034897
Beschrijving
Serious Adverse Event - Relationship to Investigatinoal Drug
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
Beschrijving
Mark one
Datatype
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
Beschrijving
If SAE is associated with Protocol design or procedures, specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0184661
- UMLS CUI [1,3]
- C0332281
- UMLS CUI [1,4]
- C2348235
Beschrijving
If SAE ist associated with another condition, specify
Datatype
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
Beschrijving
If SAE is associated with another Drug, specify
Datatype
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
Beschrijving
If yes, record details in Concomitant Medication section
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0087111
Beschrijving
Was patient withdrawn due to this specific SAE?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1519255
Beschrijving
Please provide a brief narrative description of he SAE, attaching extra pages e.g., hospital discharge summary if necessary.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0947611
Beschrijving
Serious Adverse Event #1 - Relevant Laboratory Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0587081
Beschrijving
Laboratory Test
Datatype
text
Alias
- UMLS CUI [1]
- C0022885
Beschrijving
Laboratory Test Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826641
Beschrijving
Laboratory Test Value
Datatype
text
Alias
- UMLS CUI [1]
- C0587081
Beschrijving
Laboratory Test Units
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Beschrijving
Laboratory Test Normal Range
Datatype
text
Alias
- UMLS CUI [1]
- C1096215
Beschrijving
Serious Adverse Event #1 - Signature
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2346576
Beschrijving
Confirming above data are accurate and complete.^
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2346576
Beschrijving
Investigator's Name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Investigator's Siganture Date Signed
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Medical Monitor‘s Signature
Datatype
text
Alias
- UMLS CUI [1,1]
- C1708968
- UMLS CUI [1,2]
- C1519316
Beschrijving
Medical Monitor's Name
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C1708968
Beschrijving
Medical Monitors Signature Date Signed
Datatype
date
Alias
- UMLS CUI [1,1]
- C1708968
- UMLS CUI [1,2]
- C1519316
- UMLS CUI [1,3]
- C0011008
Beschrijving
Prior and Concomitant Medications
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
Beschrijving
Prior and Concomitant Medications
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
Beschrijving
Line Number
Datatype
integer
Alias
- UMLS CUI [1]
- C0449788
Beschrijving
If a combmation drug, use Trade name.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0592502
Beschrijving
Medication Dose
Datatype
text
Alias
- UMLS CUI [1]
- C3174092
Beschrijving
Medication Units
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1519795
Beschrijving
Medication Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Medication Frequency
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
Medication Indication
Datatype
text
Alias
- UMLS CUI [1]
- C2826696
- UMLS CUI [2,1]
- C3146298
- UMLS CUI [2,2]
- C0013227
Beschrijving
Medication prior to study medication
Datatype
integer
Alias
- UMLS CUI [1]
- C2826257
- UMLS CUI [2]
- C0304229
Beschrijving
Concomitant Medication
Datatype
integer
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Medication Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
Medication End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschrijving
OR Ongoing at end of study
Datatype
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])