ID
36616
Description
Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell
Mots-clés
Versions (3)
- 26/05/2019 26/05/2019 -
- 27/05/2019 27/05/2019 - Julian Varghese
- 30/10/2019 30/10/2019 - Sarah Riepenhausen
Détendeur de droits
GlaxoSmithKline
Téléchargé le
26 mai 2019
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.
Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328
Non-Serious Adverse Event; Serious Adverse Events; Concomitant Medications
Description
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Description
SAE Sequence Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Description
Diagnosis Only (if known) Otherwise Sign/Symptom Include ONE event term only
Type de données
text
Alias
- UMLS CUI [1]
- C1519255
Description
SAE Modified term
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826302
Description
SAE MedDRA synonym
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1140263
Description
SAE MedDRA lower level term code
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3898442
Description
SAE Failed coding
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0805701
- UMLS CUI [1,3]
- C0231175
Description
SAE Start Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C1519255
Description
SAE Outcome
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Description
Serious Adverse Event - Provide End Date if Recovered/ Resolved
Type de données
date
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2,1]
- C1709863
- UMLS CUI [2,2]
- C0806020
Description
Serious Adverse Event - Provide End Date, if Recovered/ Resolved with sequelae
Type de données
date
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2,1]
- C1709862
- UMLS CUI [2,2]
- C0806020
Description
Serious Adverse Event - Provide Date of Death if fatal Outcome
Type de données
date
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2]
- C1148348
- UMLS CUI [3]
- C0206277
Description
SAE Maximum Intensity
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Description
SAE Maximum Grade
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Description
SAE Maximum Grade or Intensity
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0518690
- UMLS CUI [2,3]
- C0806909
Description
Action Taken with Investigational Product(s) as a Result of the AE
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Description
Did the subject withdraw from study including all follow up as a result of this AE?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1522577
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1274040
Description
Use best judgment at initial entry. May be amended when additional information becomes available.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
Duration of AE if < 24 hours
Type de données
durationDatetime
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1519255
Description
Time to Onset of SAE Since Last Dose
Type de données
durationDatetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0946444
- UMLS CUI [1,3]
- C0449244
Description
Was the SAE caused by activities related to study participation other than investigational product?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C3641099
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2]
- C2700391
- UMLS CUI [3]
- C0005834
- UMLS CUI [4]
- C1710661
Description
Was the event serious?
Type de données
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
Related Investigational Product
Type de données
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0439849
Description
SAE - Type of Report
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0585733
Description
Serious Adverse Event Initial Report
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0684224
- UMLS CUI [1,3]
- C0205265
Description
Serious Adverse Event Follow-Up Report
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1704685
Description
SAE- Randomisation
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0034656
Description
SAE - Seriousness
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Description
SAE - Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-3
- C2347852
Description
CM Sequence Number
Type de données
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
Description
Enter drug name, not description (Generic name preferred. If combination product, enter Trade name).
Type de données
text
Alias
- UMLS CUI [1]
- C0013227
Description
Concomitant Mediacation Modified reported term
Type de données
text
Alias
- UMLS CUI [1]
- C2826819
Description
Concomitant Medication Dose
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C3174092
Description
Concomitant Medication Unit
Type de données
text
Alias
- UMLS CUI [1]
- C2826646
Description
Concomitant Medication Frequency
Type de données
text
Alias
- UMLS CUI [1]
- C2826654
Description
Concomitant Medication Route
Type de données
text
Alias
- UMLS CUI [1]
- C2826730
Description
Concomitant Medication Start Date
Type de données
date
Alias
- UMLS CUI [1]
- C2826734
Description
Concomitant Medication Ongoing?
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
If Concomitant Medication not Ongoing, specify End Date.
Type de données
date
Alias
- UMLS CUI [1,1]
- C2826666
- UMLS CUI [1,2]
- C0806020
Description
Enter a medical diagnosis not description
Type de données
text
Alias
- UMLS CUI [1]
- C2826696
Description
Concomitant Medication Modified reported term
Type de données
text
Alias
- UMLS CUI [1]
- C2826819
Description
Drug Type
Type de données
text
Alias
- UMLS CUI [1]
- C0457591
Description
SAE - Relevant Medical Conditions/ Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C0035648
Description
Relevant medical Conditions/ Risk Factors Sequence Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035648
- UMLS CUI [1,3]
- C2348184
Description
Enter a medical diagnosis not description.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Description
Relevant Medical Conditions/ Risk Factors Modified reported term
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035648
- UMLS CUI [1,3]
- C2826302
Description
Relevant Medical Conditions/ Risk Factors Date of onset
Type de données
date
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035648
- UMLS CUI [1,3]
- C0574845
Description
Relevant Medical Conditions/ Risk Factors Continuing?
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035648
- UMLS CUI [1,3]
- C0549178
Description
If Relevant Medical Conditions/ Risk Factors not Continuing, specify date of last occurence.
Type de données
date
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035648
- UMLS CUI [1,3]
- C0549178
- UMLS CUI [1,4]
- C2745955
- UMLS CUI [1,5]
- C1517741
- UMLS CUI [1,6]
- C0011008
Description
Relevant Medical History / Risk Factors not noted above
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035648
- UMLS CUI [1,3]
- C0205394
Description
SAE - Relevant Diagnostic Results
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0430022
- UMLS CUI-3
- C0456984
Description
Lab Sequence Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Description
Lab Test Name
Type de données
text
Alias
- UMLS CUI [1]
- C0022885
Description
Lab Test Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0011008
Description
Lab Test Result
Type de données
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1274040
Description
Lab Test Units
Type de données
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1519795
Description
Lab Normal Low Range
Type de données
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0086715
- UMLS CUI [1,3]
- C0205251
Description
Lab Normal High Range
Type de données
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0086715
- UMLS CUI [1,3]
- C0205250
Description
Relevant diagnostic results not noted above
Type de données
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C0456984
- UMLS CUI [1,3]
- C0205394
Description
SAE - Rechallenge
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347900
Description
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C2745955
Description
SAE - Investigational Product
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Description
Study Drug
Type de données
text
Alias
- UMLS CUI [1]
- C0304229
Description
Investigational Product Start Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Description
Investigational Product Stop Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Description
SAE - Investigational Product
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Description
Study Drug
Type de données
text
Alias
- UMLS CUI [1]
- C0304229
Description
Investigational Product Start Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Description
Investigational Product Stop Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Description
SAE - Investigational Product
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Description
Study Drug
Type de données
text
Alias
- UMLS CUI [1]
- C0304229
Description
Investigational Product Start Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Description
Investigational Product Stop Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Description
Investigational Product Dose
Type de données
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C3174092
Description
Investigational Product Cumulative Dose
Type de données
text
Alias
- UMLS CUI [1,1]
- C2986497
- UMLS CUI [1,2]
- C0304229
Description
SAE - General Narrative Comments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Description
SAE - Non clinical
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C1298908
Description
Send incomplete SAE data to GSK Safety
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1511726
- UMLS CUI [1,3]
- C0205257
Description
Receipt by GSK date
Type de données
datetime
Alias
- UMLS CUI [1]
- C2985846
Description
Was the event serious?
Type de données
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
SAE Sequence Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Description
Version Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0333052
- UMLS CUI [1,2]
- C0237753
Description
Case ID
Type de données
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Description
Randomisation Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Description
OCEANS Code
Type de données
text
Alias
- UMLS CUI [1]
- C0805701
Description
Email Flag
Type de données
text
Alias
- UMLS CUI [1]
- C0013849
Description
Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Description
Concomitant Medications Sequence Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348184
Description
(Trade Name preferred)
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013227
Description
Concomitant Medication Modified reported term
Type de données
text
Alias
- UMLS CUI [1]
- C2826819
Description
Concomitant Medication GSK Drug synonym
Type de données
text
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C0871468
Description
Concomitant Medication GSK Drug Collection code
Type de données
text
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2,1]
- C1516698
- UMLS CUI [2,2]
- C0805701
Description
Concomitant Medication Failed coding
Type de données
text
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2,1]
- C0805701
- UMLS CUI [2,2]
- C0231175
Description
Concomitant Medication Units
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0439148
Description
Concomitant Medication Route
Type de données
text
Alias
- UMLS CUI [1]
- C2826730
Description
Concomitant Medication Reason for Medication
Type de données
text
Alias
- UMLS CUI [1]
- C2826696
Description
Concomitant Medication start date
Type de données
date
Alias
- UMLS CUI [1]
- C2826734
Description
Concomitant Medication Ongoing?
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
If Concomitant Medication not Ongoing, specify End Date
Type de données
date
Alias
- UMLS CUI [1]
- C2826666
- UMLS CUI [2]
- C0806020
Description
Concomitant Medication Total Daily Dose
Type de données
text
Alias
- UMLS CUI [1]
- C2826638
Description
Concomitant Medication Type
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0332307
Similar models
Non-Serious Adverse Event; Serious Adverse Events; Concomitant Medications
C2348184 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,2])
C3898442 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C1705586 (UMLS CUI [1,2])
C1709863 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
C1709862 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C1274040 (UMLS CUI [2,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,2])
C3898442 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1709863 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
C1709862 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
C1148348 (UMLS CUI [2])
C0206277 (UMLS CUI [3])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
C1519255 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1274040 (UMLS CUI [2,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C2700391 (UMLS CUI [2])
C0005834 (UMLS CUI [3])
C1710661 (UMLS CUI [4])
C0439849 (UMLS CUI [1,2])
C0684224 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
C1704685 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C1704686 (UMLS CUI [2,2])
C1519255 (UMLS CUI [1,2])
C2347852 (UMLS CUI-3)
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0262926 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
C0035648 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,2])
C0035648 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,3])
C0035648 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
C0035648 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0035648 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C2745955 (UMLS CUI [1,4])
C1517741 (UMLS CUI [1,5])
C0011008 (UMLS CUI [1,6])
C0035648 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
C2348184 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
C0086715 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C2745955 (UMLS CUI [2,2])
C0304229 (UMLS CUI-2)
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0304229 (UMLS CUI-2)
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0304229 (UMLS CUI-2)
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0947611 (UMLS CUI-2)
C0205210 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0871468 (UMLS CUI [2,2])
C1516698 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0439148 (UMLS CUI [1,2])
C0806020 (UMLS CUI [2])
C0332307 (UMLS CUI [1,2])