ID

30368

Description

https://clinicaltrials.gov/ct2/show/NCT00486954 Study ID: 104578 Clinical Study ID: EGF104578 Study Title: A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination with weekly Paclitaxel versus weekly Paclitaxel alone in the second line treatment of ErbB2 amplified Advanced Gastric Cancer Patient Level Data: Clinicaltrials.gov Identifier: NCT00486954 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Product Sponsorship Transferred to Novartis Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Gastrointestinal Tract CRF Seiten: 1288-1609

Lien

https://clinicaltrials.gov/ct2/show/NCT00486954

Mots-clés

30/05/2018 30/05/2018 - Halim Ugurlu

Détendeur de droits

GlaxoSmithKline (GSK)

Téléchargé le

30 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.

Retour au modèle Commentaires

Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

NCT00486954_Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer

model
Détails

NON-SERIOUS ADVERSE EVENTS, SERIOUS ADVERSE EVENTS

StudyEvent: ODM
1. NON-SERIOUS ADVERSE EVENTS, SERIOUS ADVERSE EVENTS

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

NON-SERIOUS ADVERSE EVENTS

Item Group

NON-SERIOUS ADVERSE EVENTS

C1518404 (UMLS CUI-1)

Event

Item

Event

text

C0877248 (UMLS CUI [1])

Start Date

Item

Start Date

date

C2697888 (UMLS CUI [1])

Item

Outcome

integer

C1705586 (UMLS CUI [1])

Code List

Outcome

CL Item

Recovering/resolving (1)

CL Item

Not recovered/Not resolved (2)

Outcome/End date

Item

Outcome/End date

date

C2697886 (UMLS CUI [1])

Item

Maximum Grade

integer

C0441799 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])

Code List

Maximum Grade

CL Item

Grade 1 (1)

CL Item

Grade 2 (2)

CL Item

Grade 3 (3)

CL Item

Grade 4 (4)

CL Item

Grade 5 (5)

CL Item

Not Applicable (0)

Item

Action taken with Investigational Product(s) as a result of the AE

integer

C2826626 (UMLS CUI [1])

Code List

Action taken with Investigational Product(s) as a result of the AE

CL Item

Investigational Product(s) withdrawn (1)

CL Item

Dose reduced (2)

CL Item

Dose increased (3)

CL Item

Dose not changed (4)

CL Item

Dose interrupted (5)

CL Item

Not Applicable (0)

Withdraw from study

Item

Did the subject withdraw from study as a result of this AE?

boolean

C2348571 (UMLS CUI [1])

AE may have been caused by investigational product

Item

Is there a reasonable possibility that the AE may have been caused by investigational product?

boolean

C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])

SERIOUS ADVERSE EVENTS

Item Group

SERIOUS ADVERSE EVENTS

C1519255 (UMLS CUI-1)

Item

Type of Report: Initial/Follow-Up Report

integer

C0684224 (UMLS CUI [1])

Code List

Type of Report: Initial/Follow-Up Report

CL Item

Initial Report (1)

CL Item

Follow-Up Report (2)

Randomisation

Item

Did SAE occur after initiation of study medication?

boolean

C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])

Serious Adverse Event

Item

Serious Adverse Event, Diagnosis Only (if known) Otherwise Sign/Symptom

text

C1519255 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])

Start Date

Item

Serious Adverse Event Start Date

date

C1519255 (UMLS CUI [1,1])
C2697888 (UMLS CUI [1,2])

Item

Serious Adverse Event Outcome

integer

C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])

Code List

Serious Adverse Event Outcome

CL Item

Recovering/Resolving (1)

CL Item

Not Recovered/Resolved (2)

Outcome/End Date

Item

Serious Adverse Event Outcome/End Date

date

C1519255 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])

Fatal

Item

Serious Adverse Event- Fatal

boolean

C1705586 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])

Fatal-SAE, Death Date

Item

Serious Adverse Event-Fatal, record Date of Death

date

C1705232 (UMLS CUI [1])

Item

Maximum Grade

integer

C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])

Code List

Maximum Grade

CL Item

Grade 1 (1)

CL Item

Grade 2 (2)

CL Item

Grade 3 (3)

CL Item

Grade 4 (4)

CL Item

Grade 5 (5)

CL Item

Not Applicable (0)

Item

Action taken with Investigational Product(s) as a Result of AE

integer

C2826626 (UMLS CUI [1])

Code List

Action taken with Investigational Product(s) as a Result of AE

CL Item

Investigational Product(s) withdrawn (1)

CL Item

Dose reduced (2)

CL Item

Dose increased (3)

CL Item

Dose not changed (4)

CL Item

Dose interrupted (5)

CL Item

Not Applicable (0)

Withdraw from study

Item

Did the subject withdraw from study as a result of this AE?

boolean

C2348571 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])

possibility that the AE may have been caused by investigational product

Item

Is there a reasonable possibility that the AE may have been caused by investigational product?

boolean

C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])

SAE caused by activities related to study participation

Item

Was SAE caused by activities related to study participation (e.g. procedures)?

boolean

C3641099 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])

Item

Seriousness

integer

C1710056 (UMLS CUI [1])

Code List

Seriousness

CL Item

Results in Death (1)

CL Item

Is life-threatening (2)

CL Item

Requires hospitalisation or prolongation of existing hospitalisation (3)

CL Item

Results in disability/incapacity (4)

CL Item

Congenital anomaly/birth defect (5)

CL Item

Other, specify within general narrative comment (6)

CL Item

Cardiac dysfunction/Any signs or symptoms of pneumonitis (7)

Relevant Concominant/Treatment Medications

Item Group

Relevant Concominant/Treatment Medications

C3476109 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C1519255 (UMLS CUI-3)

Drug name

Item

Drug name

text

C2360065 (UMLS CUI [1])

Dose

Item

Dose

text

C3174092 (UMLS CUI [1])

Unit

Item

Unit

text

C0439148 (UMLS CUI [1])

Frequency

Item

Frequency

text

C3476109 (UMLS CUI [1])

Route

Item

Route

text

C0013153 (UMLS CUI [1])

Start Date

Item

Start Date

date

C0808070 (UMLS CUI [1])

Ongoing?

Item

Ongoing?

boolean

C2826666 (UMLS CUI [1])

Primary Indication

Item

Primary Indication

text

C3146298 (UMLS CUI [1])

Drug Type

Item

Drug Type

text

C0457591 (UMLS CUI [1])

Relevant Medical Conditions/Risk Factors

Item Group

Relevant Medical Conditions/Risk Factors

C0262926 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)

Specific Condition Name

Item

Specific Condition Name

text

C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])

Date of Onset

Item

Date of Onset

date

C0574845 (UMLS CUI [1])

Item

Continuing

integer

C0012634 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])

Code List

Continuing

CL Item

Yes (1)

CL Item

No (2)

CL Item

Unknown (3)

If no continuation, date of last occurance

Item

If no continuation, date of last occurance

date

C2745955 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Relevant Medical History /Risk Factors not noted above

Item

Relevant Medical History /Risk Factors not noted above

text

C0262926 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])

Relevant Diagnostic Results

Item Group

Relevant Diagnostic Results

C0430022 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C1519255 (UMLS CUI-3)

Test name

Item

Test name

text

C0022885 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])

Test Date

Item

Test Date

date

C2826247 (UMLS CUI [1])

Test Result

Item

Test Result

text

C0587081 (UMLS CUI [1])

Test Ranges

Item

Test Ranges

text

C0883335 (UMLS CUI [1])

Relevant diagnostic results not noted above

Item

Relevant diagnostic results not noted above

text

C0587081 (UMLS CUI [1])

Investigational Products

Item Group

Investigational Products

C0013230 (UMLS CUI-1)

Investigational Products

Item

If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administred?

integer

C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])

Investigational Products

Code List

If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administred?

CL Item

No (1)

CL Item

Yes (2)

CL Item

Unknown at this time (3)

CL Item

Not applicable (4)

General Narrative Comments

Item Group

General Narrative Comments

C0947611 (UMLS CUI-1)
C1519255 (UMLS CUI-2)

General Narrative Comments

Item

General Narrative Comments

text

C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])

Retour au début de la page

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.