ID

36430

Description

VARGADO - Vargatef in 2nd-line Therapy of Non-Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT02392455 Brief Summary: This observational study will investigate the efficacy and tolerability of Vargatef (Nintedanib) plus docetaxel in daily routine second-line treatment in patients with locally advanced, metastatic or locally recurrent NSCLC. Treatment with Vargatef in eligible NSCLC patients, for whom the treating physician has decided to initiate treatment with Vargatef in second line according to the local label, will be observed for up to 24 months. Survial follow-up will be done until the end of the study.

Link

https://clinicaltrials.gov/show/NCT02392455

Keywords

Versions (2)
  1. 1/15/19 1/15/19 -
  2. 5/14/19 5/14/19 -
Copyright Holder

GSK group of companies

Uploaded on

May 14, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Vargatef 2nd line therapy in NSCLC NCT02392455

English

Eligibility Criteria

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Is the participant 18 or older?
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Does the participant have locally advanced, metastastic and/or recurrent NSCLC with adenocarcinoma histology for which vargatef treatment is indicated according to Summary of Product Characteristics (SmPC)?
Description

The participant should have locally advanced, metastastic and/or recurrent NSCLC with adenocarcinoma histology for which vargatef treatment is indicated according to Summary of Product Characteristics (SmPC)

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0677984
UMLS CUI [1,3]
C2939420
UMLS CUI [1,4]
C2945760
UMLS CUI [1,5]
C0344441
UMLS CUI [1,6]
C0001418
UMLS CUI [1,7]
C2700098
UMLS CUI [1,8]
C3146298
UMLS CUI [1,9]
C0332290
UMLS CUI [1,10]
C1709515
Does the participant have had first line therapy but not yet started second-line therapy?
Description

The participant should have had first line therapy but not yet started second-line therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1444637
UMLS CUI [1,2]
C1708063
UMLS CUI [2,1]
C1444646
UMLS CUI [2,2]
C1710038
Are standard 21-day-cycles docetaxel treatment according to smpc possible with the participant?
Description

Standard 21-day-cycles docetaxel treatment according to smpc should be possible

Data type

boolean

Alias
UMLS CUI [1,1]
C0246415
UMLS CUI [1,2]
C0332149
UMLS CUI [1,3]
C0332290
UMLS CUI [1,4]
C1709515
Did the participant give written informed consent?
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Are there contraindications according to the smpc of vargatef or docetaxel for the participant?
Description

Drug contraindications

Data type

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C2700098
UMLS CUI [1,3]
C1709515
UMLS CUI [2,1]
C0522473
UMLS CUI [2,2]
C0246415
UMLS CUI [2,3]
C1709515
Were there more than one systemic therapy for treatment of NSCLC in a palliative setting?
Description

Palliative systemic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0007131
UMLS CUI [1,4]
C0597023
UMLS CUI [1,5]
C0439064
Is the participant currently partcipating in another non-interventional study or a clinical trial?
Description

Study enrollment status

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521116
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C1516879
UMLS CUI [2,3]
C4684718
Is the participant pregnant?
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
Is the participant breastfeeding?
Description

Breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
Is the participant 18 or older?
boolean
C0001779 (UMLS CUI [1])
NSCLC
Item
Does the participant have locally advanced, metastastic and/or recurrent NSCLC with adenocarcinoma histology for which vargatef treatment is indicated according to Summary of Product Characteristics (SmPC)?
boolean
C0007131 (UMLS CUI [1,1])
C0677984 (UMLS CUI [1,2])
C2939420 (UMLS CUI [1,3])
C2945760 (UMLS CUI [1,4])
C0344441 (UMLS CUI [1,5])
C0001418 (UMLS CUI [1,6])
C2700098 (UMLS CUI [1,7])
C3146298 (UMLS CUI [1,8])
C0332290 (UMLS CUI [1,9])
C1709515 (UMLS CUI [1,10])
Treatment Status
Item
Does the participant have had first line therapy but not yet started second-line therapy?
boolean
C1444637 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C1444646 (UMLS CUI [2,1])
C1710038 (UMLS CUI [2,2])
Docetaxel possible
Item
Are standard 21-day-cycles docetaxel treatment according to smpc possible with the participant?
boolean
C0246415 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,3])
C1709515 (UMLS CUI [1,4])
Informed consent
Item
Did the participant give written informed consent?
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Drug contraindications
Item
Are there contraindications according to the smpc of vargatef or docetaxel for the participant?
boolean
C0522473 (UMLS CUI [1,1])
C2700098 (UMLS CUI [1,2])
C1709515 (UMLS CUI [1,3])
C0522473 (UMLS CUI [2,1])
C0246415 (UMLS CUI [2,2])
C1709515 (UMLS CUI [2,3])
Palliative systemic therapy
Item
Were there more than one systemic therapy for treatment of NSCLC in a palliative setting?
boolean
C1515119 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0007131 (UMLS CUI [1,3])
C0597023 (UMLS CUI [1,4])
C0439064 (UMLS CUI [1,5])
Study enrollment status
Item
Is the participant currently partcipating in another non-interventional study or a clinical trial?
boolean
C2348568 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C1516879 (UMLS CUI [2,2])
C4684718 (UMLS CUI [2,3])
Pregnancy
Item
Is the participant pregnant?
boolean
C0032961 (UMLS CUI [1])
Breast feeding
Item
Is the participant breastfeeding?
boolean
C0006147 (UMLS CUI [1])
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