ID
37733
Beschreibung
Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell
Stichworte
Versionen (1)
- 20.08.19 20.08.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
20. 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.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886
Serious Adverse Experiences (SAE)
- StudyEvent: ODM
Beschreibung
Serious Adverse Experience (SAE)
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Serious Adverse Event, Reporter
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0335038
Beschreibung
Serious Adverse Event
Datentyp
text
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Serious Adverse Event, Start Date, Start time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C1301880
Beschreibung
Serious Adverse Event, End Date, End time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1522314
Beschreibung
Serious Adverse Event, Adverse Event Outcome
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beschreibung
Serious Adverse Event, Course
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0750729
Beschreibung
Serious Adverse Event, Toxicity Grade
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826262
Beschreibung
Serious Adverse Event, Adverse Event Action Taken with Study Treatment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826626
Beschreibung
Serious Adverse Event, Relationships, Experimental drug
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
Beschreibung
Serious Adverse Event, Therapeutic procedure
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0087111
Beschreibung
Serious Adverse Event, Withdraw
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2349954
Beschreibung
Serious Adverse Event,Reason and justification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0566251
Beschreibung
Serious Adverse Event, Abate
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3853704
Beschreibung
Serious Adverse Event, Experimental drug, Drug dosage altered
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0420247
Beschreibung
Serious Adverse Event, Experimental drug, Drug dosage altered, Recurrence
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0420247
- UMLS CUI [1,4]
- C0034897
Beschreibung
Serious Adverse Event, Causations
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Beschreibung
Serious Adverse Event, Causations
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Beschreibung
Relevant Laboratory Data
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0587081
Beschreibung
Serious Adverse Event, Laboratory Procedures
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0022885
Beschreibung
Serious Adverse Event, Laboratory Procedures, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0022885
- UMLS CUI [1,3]
- C0011008
Beschreibung
Serious Adverse Event, Laboratory Procedures, Numerical value
Datentyp
float
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0022885
- UMLS CUI [1,3]
- C1522609
Beschreibung
Serious Adverse Event, Laboratory Procedures, Unit of Measure
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0022885
- UMLS CUI [1,3]
- C1519795
Beschreibung
Serious Adverse Event, Laboratory Procedures, Normal Range
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0022885
- UMLS CUI [1,3]
- C0086715
Beschreibung
Remarks
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Beschreibung
Randomization
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0034656
Beschreibung
Serious Adverse Event, Randomization, Revealed
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034656
- UMLS CUI [1,3]
- C0443289
Beschreibung
Serious Adverse Event, Randomization, Numbers
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034656
- UMLS CUI [1,3]
- C0237753
Beschreibung
Investigator's Signature
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2346576
Beschreibung
Serious Adverse Event, Investigator Signature
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2346576
Beschreibung
Serious Adverse Event, Investigator Signature, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2346576
- UMLS CUI [1,3]
- C0011008
Beschreibung
Serious Adverse Event, Investigator Name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826892
Ähnliche Modelle
Serious Adverse Experiences (SAE)
- StudyEvent: ODM
C1300638 (UMLS CUI [1,2])
C0335038 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C1705586 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C2826262 (UMLS CUI [1,2])
C2826626 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C3853704 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0420247 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0420247 (UMLS CUI [1,3])
C0034897 (UMLS CUI [1,4])
C0085978 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C0587081 (UMLS CUI-2)
C0022885 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0022885 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,3])
C0022885 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C0022885 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,2])
C0034656 (UMLS CUI-2)
C0034656 (UMLS CUI [1,2])
C0443289 (UMLS CUI [1,3])
C0034656 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C2346576 (UMLS CUI-2)
C2346576 (UMLS CUI [1,2])
C2346576 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C2826892 (UMLS CUI [1,2])