ID
37972
Descripción
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
Palabras clave
Versiones (1)
- 3/9/19 3/9/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
3 de septiembre de 2019
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
Descripción
Are there any non-serious adverse events to report?
Alias
- UMLS CUI-1
- C1518404
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1518404
Descripción
Non-Serious adverse Events
Alias
- UMLS CUI-1
- C1518404
Descripción
Non-Serious adverse Event
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1518404
Descripción
Non-Serious adverse Event Onset Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2985916
- UMLS CUI [1,2]
- C1518404
Descripción
Non-Serious adverse Event End Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Descripción
(If died, STOP; go to SAE section and follow instructions)
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Descripción
Non-Serious adverse Event Experience Course
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0750729
Descripción
Non-Serious adverse Event Common Toxicity Grade
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2826262
Descripción
Non-Serious adverse Event - Action Taken with Respect to investigational Drug
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2826626
Descripción
Non-Serious adverse Event - Relationship to Investigational Drug
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Descripción
If yes, record details in Concomitant Medication section
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0087111
Descripción
Was patient withdrawn due to this specific AE?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Descripción
Serious Adverse Event #1
Alias
- UMLS CUI-1
- C1519255
Descripción
Serious Adverse Event
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1519255
Descripción
Person Reporting SAE:
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C1519255
Descripción
Serious Adverse Event Onset Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2985916
- UMLS CUI [1,2]
- C1519255
Descripción
Serious Adverse Event Onset Time
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449244
Descripción
Serious Adverse Event End Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
Descripción
Serious Adverse Event End Time
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1522314
Descripción
Mark all that apply
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0392360
Descripción
If other reason(s) for considering this an SAE, specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Descripción
Serious Adverse Event Outcome
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Descripción
Serious Adverse Event - Experience Course
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0750729
Descripción
Serious Adverse Event - Common Toxicity Grade
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826262
Descripción
Serious Adverse Event - Action Taken with Respect to Investigational Drug
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826626
Descripción
Did the SAE abate?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3853704
Descripción
If study medication was interrupted, stopped, or dose reduced, was study Medication reintroduced (or dose decresed)?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1707811
Descripción
If study Medication was reintroduced, did SAE recur?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1707811
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0034897
Descripción
Serious Adverse Event - Relationship to Investigatinoal Drug
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
Descripción
Mark one
Tipo de datos
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
Descripción
If SAE is associated with Protocol design or procedures, specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0184661
- UMLS CUI [1,3]
- C0332281
- UMLS CUI [1,4]
- C2348235
Descripción
If SAE ist associated with another condition, specify
Tipo de datos
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
Descripción
If SAE is associated with another Drug, specify
Tipo de datos
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
Descripción
If yes, record details in Concomitant Medication section
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0087111
Descripción
Was patient withdrawn due to this specific SAE?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1519255
Descripción
Please provide a brief narrative description of he SAE, attaching extra pages e.g., hospital discharge summary if necessary.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0947611
Descripción
Serious Adverse Event #1 - Relevant Laboratory Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0587081
Descripción
Laboratory Test
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0022885
Descripción
Laboratory Test Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2826641
Descripción
Laboratory Test Value
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0587081
Descripción
Laboratory Test Units
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0587081
Descripción
Laboratory Test Normal Range
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1096215
Descripción
Serious Adverse Event #1 - Signature
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2346576
Descripción
Confirming above data are accurate and complete.^
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2346576
Descripción
Investigator's Name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826892
Descripción
Investigator's Siganture Date Signed
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Descripción
Medical Monitor‘s Signature
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1708968
- UMLS CUI [1,2]
- C1519316
Descripción
Medical Monitor's Name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C1708968
Descripción
Medical Monitors Signature Date Signed
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1708968
- UMLS CUI [1,2]
- C1519316
- UMLS CUI [1,3]
- C0011008
Descripción
Prior and Concomitant Medications
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
Descripción
Prior and Concomitant Medications
Alias
- UMLS CUI-1
- C2826257
- UMLS CUI-2
- C2347852
Descripción
Line Number
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0449788
Descripción
If a combmation drug, use Trade name.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0592502
Descripción
Medication Dose
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3174092
Descripción
Medication Units
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1519795
Descripción
Medication Route
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0013153
Descripción
Medication Frequency
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3476109
Descripción
Medication Indication
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826696
- UMLS CUI [2,1]
- C3146298
- UMLS CUI [2,2]
- C0013227
Descripción
Medication prior to study medication
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2826257
- UMLS CUI [2]
- C0304229
Descripción
Concomitant Medication
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2347852
Descripción
Medication Start Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Descripción
Medication End Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Descripción
OR Ongoing at end of study
Tipo de datos
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])