ID
30140
Description
Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853
Mots-clés
Versions (2)
- 14/05/2018 14/05/2018 -
- 15/05/2018 15/05/2018 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
15 mai 2018
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
Oral GW786034 treatment for ovarian cancer NCT00281632
Visit description: Treatment Period 2. Day 1
- StudyEvent: ODM
Description
Vital signs
Description
Heart rate
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Blood pressure, systolic
Type de données
integer
Unités de mesure
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Description
Blood pressure, diastolic
Type de données
integer
Unités de mesure
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Description
Temperature
Type de données
float
Unités de mesure
- ° C
Alias
- UMLS CUI [1]
- C0039476
Description
ECOG Performance Status
Alias
- UMLS CUI-1
- C1520224
Description
Electronically transferred laboratory data - CA-125
Alias
- UMLS CUI-1
- C0200345
- UMLS CUI-2
- C0022885
- UMLS CUI-3
- C0201549
Description
Physical examination
Alias
- UMLS CUI-1
- C0031809
Description
physical examination
Type de données
boolean
Alias
- UMLS CUI [1]
- C0031809
Description
Examination Status
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0449438
Description
abnormal physical examination
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0459424
Description
Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Description
Adverse Events
Alias
- UMLS CUI-1
- C0877248
Description
Local Laboratory - Haematology
Alias
- UMLS CUI-1
- C0474523
- UMLS CUI-2
- C0022885
Description
Lab ID
Type de données
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0600091
Description
Laboratory name
Type de données
text
Alias
- UMLS CUI [1]
- C1882331
Description
Laboratory Address
Type de données
text
Alias
- UMLS CUI [1]
- C3262820
Description
Date Sample taken Haematology
Type de données
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0018941
- UMLS CUI [1,3]
- C1302413
Description
Haematocrit (HCT)
Type de données
float
Alias
- UMLS CUI [1]
- C0018935
Description
Haemoglobin (Hb)
Type de données
float
Alias
- UMLS CUI [1]
- C0518015
Description
Platelet count (absolute)
Type de données
float
Alias
- UMLS CUI [1]
- C0032181
Description
White blood cell count (WBC) (Absolute)
Type de données
float
Alias
- UMLS CUI [1]
- C0023508
Description
Neutrophil count (absolute)
Type de données
float
Alias
- UMLS CUI [1]
- C0948762
Description
Lymphocyte count (absolute)
Type de données
float
Alias
- UMLS CUI [1]
- C3544087
Description
Local Laboratory - Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0022885
Description
Lab ID
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0600091
Description
Laboratory name
Type de données
text
Alias
- UMLS CUI [1]
- C1882331
Description
Laboratory Address
Type de données
text
Alias
- UMLS CUI [1]
- C3262820
Description
Date sample taken
Type de données
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C1302413
Description
Alkaline phosphatase
Type de données
float
Alias
- UMLS CUI [1]
- C0201850
Description
ALT (SGPT)
Type de données
float
Alias
- UMLS CUI [1]
- C0201836
Description
AST (SGOT)
Type de données
float
Alias
- UMLS CUI [1]
- C0201899
Description
Albumin
Type de données
float
Alias
- UMLS CUI [1]
- C0201838
Description
Total bilirubin
Type de données
float
Alias
- UMLS CUI [1]
- C0201913
Description
BUN
Type de données
float
Alias
- UMLS CUI [1]
- C0005845
Description
Calcium
Type de données
float
Alias
- UMLS CUI [1]
- C0201925
Description
Serum Creatinine
Type de données
float
Alias
- UMLS CUI [1]
- C0201976
Description
Glucose (fasting)
Type de données
float
Alias
- UMLS CUI [1]
- C0583513
Description
LDH
Type de données
float
Alias
- UMLS CUI [1]
- C0202113
Description
Potassium
Type de données
float
Alias
- UMLS CUI [1]
- C0202194
Description
Sodium
Type de données
float
Alias
- UMLS CUI [1]
- C0337443
Description
TSH in serum
Type de données
float
Alias
- UMLS CUI [1]
- C0202230
Description
T4
Type de données
float
Alias
- UMLS CUI [1]
- C0040165
Description
Lipase
Type de données
float
Alias
- UMLS CUI [1]
- C0373670
Description
Amylase
Type de données
float
Alias
- UMLS CUI [1]
- C0201883
Description
Urinalysis
Alias
- UMLS CUI-1
- C0042014
Description
Date sample taken
Type de données
date
Alias
- UMLS CUI [1]
- C1302413
Description
Laboratory name
Type de données
text
Alias
- UMLS CUI [1]
- C3258037
Description
Address
Type de données
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Description
UPC ratio
Type de données
float
Alias
- UMLS CUI [1,1]
- C1524119
- UMLS CUI [1,2]
- C0033684
- UMLS CUI [1,3]
- C1522609
Description
Lab ID
Type de données
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0600091
Description
Pharmacokinetics - Blood
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C0005767
Description
Planned Relative Time
Type de données
text
Alias
- UMLS CUI [1]
- C0439564
Description
Date Sample Taken
Type de données
date
Alias
- UMLS CUI [1]
- C1302413
Description
Actual Time
Type de données
time
Alias
- UMLS CUI [1]
- C0040223
Description
Sample Identifier
Type de données
text
Alias
- UMLS CUI [1]
- C4071975
Description
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Description
Planned timepoint
Type de données
text
Alias
- UMLS CUI [1]
- C2348792
Description
investigational product
Type de données
text
Alias
- UMLS CUI [1]
- C0304229
Description
Investigational Product Date of Dose
Type de données
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0011008
Description
Investigational Product Time of Dose
Type de données
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0040223
Description
Dose
Type de données
float
Unités de mesure
- mg/Day
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0304229
Description
Biomarker sample(s)
Alias
- UMLS CUI-1
- C0005516
Description
Biomarker Sample Type
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347029
- UMLS CUI [1,2]
- C0005516
Description
Biomarker sample collected
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0005516
- UMLS CUI [1,2]
- C0200345
Description
If no, reason
Type de données
text
Alias
- UMLS CUI [1]
- C0681841
Description
Date sample taken
Type de données
date
Alias
- UMLS CUI [1]
- C1302413
Description
Time sample taken
Type de données
partialDatetime
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Description
INVESTIGATIONAL PRODUCT
Alias
- UMLS CUI-1
- C0304229
Description
investigational product
Type de données
text
Alias
- UMLS CUI [1]
- C0304229
Description
medication dosage
Type de données
integer
Unités de mesure
- mg/day
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0304229
Description
start date
Type de données
date
Alias
- UMLS CUI [1]
- C0808070
Description
stop date
Type de données
date
Alias
- UMLS CUI [1]
- C0806020
Description
investigational product container number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C3898691
- UMLS CUI [1,2]
- C0449788
Description
reason for dosing deviations changes
Type de données
text
Alias
- UMLS CUI [1,1]
- C1515926
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0392360
Description
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Description
Planned timepoint
Type de données
text
Alias
- UMLS CUI [1]
- C2348792
Description
investigational product
Type de données
text
Alias
- UMLS CUI [1]
- C0304229
Description
Investigational Product Date of Dose
Type de données
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0011008
Description
Investigational Product Time of Dose
Type de données
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0040223
Description
Dose
Type de données
float
Unités de mesure
- mg/Day
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0304229
Description
Treatment Confirmation
Alias
- UMLS CUI-1
- C0750484
- UMLS CUI-2
- C0087111
Description
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C0087111
Description
If No, record reason(s)
Type de données
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0750484
- UMLS CUI [1,3]
- C0087111
Similar models
Visit description: Treatment Period 2. Day 1
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0022885 (UMLS CUI-2)
C0201549 (UMLS CUI-3)
C0201549 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
C0459424 (UMLS CUI [1,2])
C0022885 (UMLS CUI-2)
C0600091 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
C0022885 (UMLS CUI-2)
C0600091 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0033684 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,2])
C0005767 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0087111 (UMLS CUI-2)
C0087111 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])